Holistic Health Pillars

What is Holistic Health? Holistic health practitioners work with clients to achieve specific health goals. This may include improving athletic performance, disease prevention, and the treatment of symptoms. Holistic nutritionists may help implement anti-inflammatory diets. Holistic health practitioners work with both medical professionals and the public to implement a personalized plan of action. Holistic health…

What is Holistic Health? Holistic health practitioners work with clients to achieve specific health goals. This may include improving athletic performance, disease prevention, and the treatment of symptoms. Holistic nutritionists may help implement anti-inflammatory diets. Holistic health practitioners work with both medical professionals and the public to implement a personalized plan of action. Holistic health practitioners are available in many locations, and many practices are affiliated with local hospitals and clinics.

Eight pillars that support holistic health

A balanced diet is a key component of the physical wellness pillar. In addition to eating more fruits and vegetables, you should also be eating a variety of whole grains. Avoid foods with high amounts of sodium, cholesterol, or added sugar. Likewise, you should avoid fried foods. These foods can contribute to high cholesterol levels, which can have negative effects on your overall health. A healthy diet can improve many of the other pillars.

The physical and emotional aspects of health go hand in hand. Holistic health acknowledges the role of mental, spiritual, and social aspects of health. As a result, it takes the whole person into account, focusing on the connections between the body, mind, and environment. Emotional wellness is an important component of holistic health, and it can be cultivated through the eight pillars of holistic health. Listed below are the eight pillars of holistic health.

Physical health: Exercise, diet, sleep habits, hygiene, and personal hygiene are important aspects of physical health. Physical health requires adequate exercise, good rest, and a clean environment. Physical health is just the tip of the iceberg, though. It also requires that you understand your body’s chemistry and how to balance it. Nutrition is an essential part of physical health, and it gets its own pillar. Taking care of your body’s chemistry is important when making dietary and lifestyle decisions.

Cost control

There are two methods of cost control in holistic health care. One is to measure the cost of an entire system and implement changes in management based on results. Cost control in holistic health care is often difficult to achieve because costs vary according to the type of treatment provided. The other method is to identify the cost of an individual patient, and to measure the proportion of that patient who will need further care. Although holistic health care is more expensive than usual medical care, it is cost effective and can reduce mortality.

The first strategy is a health share plan, which requires the members to pay a portion of the cost of their care. These plans are more expensive than traditional medical care, but are often more effective because they treat the whole person and encourage preventative care. This approach also keeps costs low and satisfaction high, leaving more money for major medical events. The most common holistic health care costs are due to chronic illnesses and other conditions. The costs of a health share plan are shared by all members.

Another strategy for cost control in holistic health care is to use health policy commissions. The Maryland commission, for example, has been focusing on the total cost of care and hospital budgets. It has a history, and stakeholders have a vested interest in working with it. In Maryland, a Medicare waiver encourages health care providers to offer services to all payers, such as Medicare and Medicaid. These charges are then offset by increases in commercial rates.

Prevention of disease

The American Holistic Health Association advocates for the prevention of chronic disease. The emphasis on holistic health entails treating the entire person, incorporating the mind, body, and spirit into a health-promoting lifestyle. The most difficult aspects of incorporating holistic practices into the client’s life are often changes to food, which can be hard for clients to accept. However, the benefits of holistic health far outweigh the negative effects.

One of the most significant benefits of preventive medicine is lower healthcare costs. The Centers for Disease Control and Prevention report that the practice of prevention can reduce costs by more than $1 trillion annually. In fact, 90 percent of healthcare expenditures are related to chronic conditions. Preventive care focuses on the prevention of chronic disease by emphasizing long-term health, healthy pregnancy, and aging. Health screenings are an important component of this holistic approach.

The benefits of holistic medicine are numerous. First, holistic doctors focus on the whole person, rather than simply treating the symptoms of an illness. Holistic physicians believe that the mind-body connection is the key to healing. As such, holistic doctors help patients develop an understanding of their entire health profile. By integrating complementary therapies and Western medicine, holistic physicians can treat the whole person and prevent or improve disease symptoms. In addition to reducing disease risk, holistic health also emphasizes a strong doctor-patient relationship.

Medicinal plants

Medicinal plants can be used to treat various illnesses and diseases. Using them can be a natural way to improve your overall health and well-being. Here are some tips for maximizing their benefits. Read on to learn how to use medicinal plants in your daily life. We are going to go over a few examples of the most popular ones and how they can improve your health. Listed below are some of their most important benefits.

Traditional medicines have their place, but plants play a vital role in drug development. Modern scientific techniques have helped verify the ancient knowledge of the healer. These traditional remedies incorporate many aspects of the body, including their chemical composition and their psychological effects. As a result, the study of traditional medicine is helping to discover future drug leads. Medicinal plants are used in many countries and have played a vital role in traditional healthcare systems for thousands of years. Today, about 50% of all drugs that are used in clinical practice are made from natural products.

Besides examining their properties, medicinal plants can also be used for cancer treatment. The research study documented the different plant species used in cancer management among Tswana speakers. The study also provided baseline data for further studies. Future studies will focus on the phytochemical and pharmacological profiles of these plants. The findings of this study have opened the door to further investigation into the effects of these plants on the human body. It also highlights the growing popularity of natural products.

Dietary supplements

The goal of dietary supplements for holistic health is to help people improve their health and well-being by addressing the root causes of the disease. Researchers and practitioners of holistic nutrition know that the body’s chemical processes are continuously occurring. They are affected by synthetic chemicals, which disrupt these processes. They also know that abnormal substances can interfere with decision-making and brain functions. Consequently, these substances may cause long-term damage. Instead of taking synthetic chemicals, holistic nutritionists recommend natural foods and herbal supplements.

A good source for dietary supplements is the Office of Dietary Supplements. This organization helps consumers find information on dietary supplements and answers questions about their efficacy. You can also contact the manufacturers to find out more about the supplement’s ingredients and efficacy. In addition, you can visit the National Center for Complementary and Integrative Health (NCCIH) or Office of Dietary Supplements, which have websites designed to help consumers make informed choices.

Some people have tried using dietary supplements for holistic health. However, their use is not recommended for everyone. These supplements are not meant to diagnose or treat diseases and are not as safe as medicines. However, they are effective in enhancing the current routine of a person. They are not a replacement for good eating habits. A healthy diet and exercise are important factors for holistic health. And you should not neglect your diet and your health if you want to see significant results from dietary supplements.

Alternative medicine

Holistic health is all about using the correct methods to achieve optimal health. Alternative medicine attempts to achieve the same effects as medicine, but is not scientifically proven. It has no biological plausibility and has been proven ineffective. Nonetheless, many people swear by it and use it for a wide variety of conditions. Below are some common examples of complementary and alternative medicine. Read on to learn more about the benefits and limitations of alternative medicine.

A holistic philosophy views the mind, body, and spirit as one. A dysfunction in one area affects the whole person. Complementary medicine is guided by this philosophy. Many Australians seek out alternative medicine after feeling dissatisfied with conventional medical care. They don’t believe in the harsh side effects of conventional drugs. It may be more gentle and safer. In addition, it involves a collaborative approach with both the patient and provider.

The holistic health care provider may prescribe medicines and surgical procedures to treat acute or chronic pain, or recommend exercise to boost the production of endorphins. Regardless of the condition, a holistic health care provider may also ask about your diet and lifestyle, identifying foods that contribute to inflammation and stress. If you suffer from pain, your holistic health care provider may recommend acupuncture or massage therapy, or even mindful meditation to relieve tension and stress.

Edluar (zolpidem tartrate) for Insomnia: Side Effects & Warnings

What is Edluar (zolpidem tartrate), and what is it used for?

Edluar is a sedative-hypnotic (sleep) medicine. Edluar is used in adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).

It is not known if Edluar is safe and effective in children under the age of 18 years.

Edluar is a class four (C-IV) federally controlled substance because it can be abused or lead to dependence. Keep Edluar in a safe place to prevent misuse and abuse. Selling or giving away Edluar may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

What are the side effects of Edluar?

Edluar may cause serious side effects, including:

  • getting out of bed while not being fully awake and doing an activity that you do not know you are doing. 
  • abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, suicidal thoughts or actions.
  • memory loss
  • anxiety
  • severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing. Get emergency medical help if you get these symptoms after taking Edluar.

Call your healthcare provider right away if you have any of the above side effects or any other side effects that worry you while using Edluar.

The most common side effects of Edluar are:

You may still feel drowsy the next day after taking Edluar.

After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as:

These are not all the side effects of Edluar. Ask your doctor or pharmacist for more information.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Is Edluar addictive?

Drug Abuse And Dependence

Controlled Substance

Edluar contains the same active substance, zolpidem tartrate, as zolpidem tartrate oral tablets and is classified as a Schedule IV controlled substance by federal regulation.

Abuse
  • Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. Tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects.
  • Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common.
  • Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg was difficult to distinguish from placebo.
  • Because persons with a history of addiction to or abuse of, drugs or alcohol are at increased risk for misuse, abuse, and addiction of Edluar, they should be monitored carefully when receiving Edluar or any other hypnotic.
Dependence
  • Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.
  • Sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions.
  • The following adverse events which are considered to meet the DSM-III-R criteria for uncomplicated sedative/hypnotic withdrawal were reported during U.S. clinical trials following placebo substitution occurring within 48 hours following last zolpidem tartrate treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and abdominal discomfort. These reported adverse events occurred at an incidence of 1% or less. However, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. Post-marketing reports of abuse, dependence and withdrawal have been received.

What is the dosage for Edluar?

Dosage In Adults

  • Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness. The total dose of Edluar should not exceed 10 mg once daily immediately before bedtime.
  • The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

Special Populations

  • Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Edluar in both of these patient populations is 5 mg once daily immediately before bedtime.

Use With CNS Depressants

  • Dosage adjustment may be necessary when Edluar is combined with other CNS-depressant drugs because of the potentially additive effects.

Administration

  • The effect of Edluar may be slowed by ingestion with or immediately after a meal.
  • Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.

What drugs interact with Edluar?

CNS-active Drugs

CNS Depressants
  • Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs.
Imipramine, Chlorpromazine
  • Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance.
Haloperidol
  • A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration.
Alcohol
  • An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated.
Sertraline
  • Concomitant administration of zolpidem and sertraline increases exposure to zolpidem and may increase the pharmacodynamics effect of zolpidem.
Fluoxetine
  • After multiple doses of zolpidem tartrate and fluoxetine an increase in the zolpidem half-life (17%) was observed. There was no evidence of an additive effect in psychomotor performance.
Drugs That Affect Drug Metabolism Via Cytochrome P450
  • Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of other P450 enzymes on the exposure to zolpidem is not known.
Rifampin
  • Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamics effects of zolpidem. Use of Rifampin in combination with zolpidem may decrease the efficacy of zolpidem.
Ketoconazole
  • Ketoconazole, a potent CYP3A4 inhibitor, increased the pharmacodynamics effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together.

Edluar contraindications, and pregnancy and breastfeeding safety

Pediatric Use

Edluar is not recommended for use in children. Safety and effectiveness in pediatric patients have not been established in pediatric patients below the age of 18.

Pregnancy

Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation.

Breastfeeding

Limited data from published literature reports the presence of zolpidem in human milk. There are reports of excess sedation in infants exposed to zolpidem through breastmilk. There is no information on the effects of zolpidem on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Edluar and any potential adverse effects on the breastfed infant from Edluar or from the underlying maternal condition.

Why Do People Sleepwalk? Causes, Symptoms & Treatment

Sleepwalking may include sitting up, walking around, and doing complex activities while appearing awake. It typically happens while in a deep sleep.
Sleepwalking may include sitting up, walking around, and doing complex activities while appearing awake. It typically happens while in a deep sleep.

Sleepwalking characteristically occurs during the first or second sleep cycles, specifically, during stages III and IV, otherwise known as deep sleep. Due to the short time frame involved, sleepwalking tends not to occur during naps.

Sleepwalking activities may include simply sitting up and appearing awake while remaining asleep, getting up and walking around, or complex activities such as moving furniture, going to the bathroom, dressing, and undressing, and similar activities. Some people even drive a car while actually asleep. The episode can be very brief (a few seconds or minutes) or can last for 30 minutes or longer.

Upon waking, the sleepwalker has no memory of his or her behaviors.

Sleepwalking has been described in medical literature dating before Hippocrates (460 BC-370 BC). In Shakespeare's tragic play, Macbeth, Lady Macbeth's famous sleepwalking scene ("out, damned spot") is ascribed to her guilt and resulting insanity as a consequence of her involvement in the murder of her father-in-law.

Parasomnias are a group of sleep behaviors common in children, teens, and occasionally adults. To understand parasomnias, it is helpful to understand the physiology of sleep.

Sleep occurs in two broad categories defined by characteristic changes during an EEG (electroencephalogram, “brain wave test”). The two categories are REM (rapid eye movement) and non-REM (NREM) sleep cycles. Non-REM sleep has four “levels” characterized by unique patterns of the EEG.

  • Stage I: introduction to sleep during which there is generalized muscle relaxation and effort is required to keep your eyes open.
  • Stage II: beginning to sleep (light sleep)
  • Stage III and IV: deep sleep
  • REM sleep: associated with dreaming

An entire sleep cycle from Stage I (non-REM) thru REM sleep lasts between 90 and-120 minutes and repeats 4 to 5 times during the sleep experience. Each “level” of non-REM and REM sleep lasts between 5 to 15 minutes.

A large Canadian study reviewed sleep patterns of children aged 2.5 to 6 years and discovered approximately 88% of them experienced parasomnias, and 15% were sleepwalkers.

Other signs and symptoms associated with sleepwalking were:

  • (1) sleep terrors (40%),
  • (2) sleep enuresis (bedwetting, 25%),
  • (3) bruxism (grinding of the teeth, 46%), and
  • (4) rhythmic movements (such as head banging, 9%).

What is sleepwalking?

Sleepwalking is characterized by a complex action behavior (walking) during sleep. Occasionally, the person may talk, but it does not make sense. The person's eyes are commonly open, but have a characteristic glassy "look right through you" character.

Sleepwalking most commonly occurs during early childhood and less commonly during adolescence.

Sleepwalking definition and facts

  • Sleepwalking is relatively common in younger children and the frequency is much less in adolescents.
  • Although disruptive and frightening for parents in the short term, sleepwalking is not associated with long-term complications.
  • Factors predisposing to sleepwalking are genetic influences, environmental influences, and physiologic factors.
  • The diagnosis of sleepwalking with history and exam. Laboratory or radiological studies rarely are necessary.
  • Several conditions are similar to sleepwalking so the doctor will need to eliminate them in order to diagnose sleepwalking.
  • There are treatments options to consider when dealing with a child who sleepwalks.
  • The outlook for the resolution of the disorder is excellent.

What do you do when someone is sleepwalking? Should you wake them up?

  • One common misconception is that a person sleepwalking should not be awakened. It is not dangerous to awaken a sleepwalker, although it is common for the person to be confused or disoriented for a short time when awake.
  • Another misconception is that a person cannot be injured while sleepwalking.
  • Injuries caused by sleepwalking, for example, tripping and loss of balance, are common.

Sleepwalking Causes: Fatigue

Tiredness is not a symptom that defines any one particular disease. Rather, tiredness can be a symptom of many different diseases and conditions. Causes of tiredness range from lack of sleep and over exercise to medical and surgical treatments. The lack of energy associated with tiredness can sometimes cause difficulty with normal daily activities, leading to problems with attentiveness and concentration.

Fatigue, in medical terminology, refers to the state of reduced capacity for work or accomplishment following a period of mental or physical activity. For example, muscles fatigue if the are called upon to repetitively work for an extended period. Most of the causes of tiredness are also associated with fatigue.

Read more about fatigue, one of the causes of sleepwalking »

What is the cause of sleepwalking?

Sleepwalking seems to be associated with inherited (genetic), environmental, physiologic, and medical factors.

Genetic factors

One study documented that sleepwalking is ten times more likely to occur if a first-degree relative has a history of sleepwalking.

Environmental factors

Sleep deprivation, chaotic sleep schedules, fever, stress, magnesium deficiency, and alcohol intoxication can trigger sleepwalking. Drugs, for example, sedative/hypnotics (drugs that promote sleep), neuroleptics (drugs used to treat psychosis), minor tranquilizers (drugs that produce a calming effect), stimulants (drugs that increase activity), and antihistamines (drugs used to treat symptoms of allergies) associated with an increased likelihood of sleepwalking.

Physiologic factors

Physiologic factors that may contribute to sleepwalking include:

What are symptoms of sleepwalking? How can you tell if they are sleepwalking?

Following are examples of symptoms of sleepwalking.

  • Episodes range from quiet walking around the room to agitated running or attempts to "escape." The person sleepwalking may appear clumsy and dazed in his or her behavior.
  • Typically, the eyes are open with a glassy, staring appearance as the person quietly roams around the house. However, they do not walk with their arms extended in front of them as is inaccurately depicted in movies.
  • On questioning the person's sleepwalking, responses are slow with simple thoughts and contain nonsense phraseology or absent responses. If the person is returned to bed without awakening, they usually do not remember the event.
  • Older children, who may awaken more easily at the end of an episode, often are embarrassed by the behavior (especially if it was inappropriate). Instead of walking, some children perform repeated behaviors (such as straightening their pajamas). Bedwetting may also occur.
  • Sleepwalking is not associated with previous sleep problems, sleeping alone in a room or with others, fear of the dark (achluophobia), or anger outbursts.
  • Some studies suggest that children who sleepwalk may have been more restless sleepers between the ages of four and five, and more restless with more frequent awakenings during the first year of life.

What tests diagnose sleepwalking?

  • Usually, no exams and tests are necessary. However, a medical evaluation may be completed to rule out medical causes of sleepwalking.
  • Occasionally, a psychological evaluation can determine whether excessive stress or anxiety is the cause of sleepwalking.
  • Sleep study tests may be done in persons in whom the diagnosis is still unclear.

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How do you stop sleepwalking? What is the treatment or cure?

Sleepwalking Home Remedies

A person who has a sleepwalking disorder can take the following measures:

  • get adequate sleep;
  • meditate or do relaxation exercises;
  • avoid any kind of stimuli (auditory or visual) prior to bedtime;
  • keep a safe sleeping environment, free of harmful or sharp objects;
  • sleep in a bedroom on the ground floor if possible to prevent falls and avoid bunk beds;
  • lock the doors and windows;
  • remove obstacles in the room, tripping over toys or objects is a potential hazard;
  • cover glass windows with heavy drapes; and
  • place an alarm or bell on the bedroom door and if necessary on any windows.

Medical treatments

Sleepwalking may be associated with an underlying medical condition, for example, gastroesophageal reflux disease (GERD), obstructive sleep apnea, periodic leg movements (restless leg syndrome), or seizures. To help prevent sleepwalking, underlying medical condition should be treated.

Medications for the treatment of sleepwalking disorder may be necessary in the following situations:

  • when the possibility of injury is real;
  • when continued behaviors are causing significant family disruption or excessive daytime sleepiness; and
  • when other measures have proven to be inadequate.

Medications

Benzodiazepines, such as estazolam (ProSom), or tricyclic antidepressants, such as trazodone (Desyrel), have been shown to be useful. Clonazepam (Klonopin) in low doses before bedtime and continued for three to 6 weeks is usually effective.

Medication can often be discontinued after three to 5 weeks without recurrence of symptoms. Occasionally, the frequency of episodes increases briefly after discontinuing the medication.

Other remedies

Relaxation techniques, mental imagery, and anticipatory awakenings are preferred for long-term treatment of persons with sleepwalking disorder.

  • Relaxation and mental imagery should be undertaken only with the help of an experienced behavioral therapist or hypnotist.
  • Anticipatory awakenings consist of waking the child or person approximately 15-20 minutes before the usual time of an event, and then keeping him or her awake through the time during which the episodes usually occur.




QUESTION

Why do we sleep?
See Answer

What other sleep conditions have similar symptoms of sleepwalking?

Sleepwalking, night terrors and confusional arousals are all related, common non-REM sleep disorders that tend to overlap in some of their symptoms. Approximately 15%-20% of young children through mid-adolescence will experience some or all of these behaviors. Moreover, seizures occurring during sleep (nocturnal seizures) can cause movement disorders during sleeping.

  • Night terrors: Like sleepwalking, night terrors tend to occur during the first half of a night's sleep – often within 30 to 90 minutes from falling asleep.
    • Also like sleepwalking, they occur during stage III of non-REM sleep. However, unlike sleepwalking, an individual with night terrors will portray sudden and often agitated arousal that may appear to parents as violent and terrifying behaviors. During such an episode, the child characteristically will not be comforted by an embrace from a parent or caregiver.
    • Night terrors often start during the toddler years with a peak incidence between five and seven years of age. During these times evidence of a surge in autonomic nervous system activity is evident. Accelerated heart and respiratory rates, dilated pupils, and sweating is characteristic.
    • Triggers for night terrors may include sleep deprivation, stress, and medications (stimulants, sedatives, antihistamines, etc). Unlike sleepwalking, episodes of night terrors may recur for several weeks in a row, abate completely, and later return.
  • Confusional arousals: Similar to night terrors, confusional arousals are characterized by a sudden and violent arousal from sleep with behaviors described as agitated and semi-purposeful in the pattern.
    • Speech is generally coherent (unlike sleepwalking).
    • A distinguishing point between night terrors and confusional arousals is the lack of autonomic nervous system (accelerated heart/respiratory rates, dilated pupils, sweating) phenomena in the latter.
    • Confusional arousals tend to occur during the first half of a night's sleep (during stage II non-REM sleep). They are characteristically short-lived, lasting 5 to 15 minutes but can last up to 30 minutes in duration. Amnesia for the event is characteristic.
  • Nocturnal seizures: Several important differential points help delineate the above three sleep behaviors from seizure activity. Seizures by their nature are very brief, often lasting only a few minutes.
    • In addition, seizure events are likely to be confused with the above; and are characterized by a series of repeated, stereotypical, and frequent behaviors occurring in clusters.
    • Moreover, seizures more commonly occur in the second half of the night's sleep. Patients often will have postictal (symptoms after the seizure) complications such as headache, extreme grogginess, hard to arouse, as well as incontinence of urine and stool.
    • To assist in establishing a correct diagnosis a neurologist may perform a video-EEG study to help clarify the issue. Home videos taken on a smartphone are often very helpful in establishing the diagnosis.

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What are the complications of sleepwalking?

A common complication is an injury sustained during sleepwalking activities.

How can you prevent sleepwalking?

  • Avoid the use of alcohol or central nervous system depressants if prone to sleepwalking.
  • Avoid fatigue or insomnia, because this can instigate an episode of sleepwalking.
  • Avoid or minimize stress, anxiety, and conflict, which can worsen the condition.

What is the prognosis of sleepwalking?

Sleepwalking may or may not reduce with age, as described above. It usually does not indicate a serious disorder, although it can be a symptom of other disorders.

When should you call your health care professional about sleepwalking?

Sleepwalking usually does not require a visit to your healthcare professional. However, the condition should be discussed with your healthcare professional if sleepwalking:

  • is accompanied by other symptoms,
  • is frequent or persistent, or
  • includes potentially dangerous activities (such as driving).
  • If you have any history of strange activity or sleepwalking while taking medications for insomnia like zolpidem (Ambien), you should also speak to your physician.

Why Can’t I Sleep by Myself?

There are several reasons why it's hard to fall asleep alone, but there are many things you can do to combat the problem. You may have a hard time sleeping by yourself because of fear, bad habits, hormones or grief.
There are several reasons why it's hard to fall asleep alone, but there are many things you can do to combat the problem. You may have a hard time sleeping by yourself because of fear, bad habits, hormones or grief.

You are all alone in your home and it’s time to hit the bed. The mere thought of sleeping alone makes you feel creepy. You are not alone. Many people struggle to fall asleep, especially when they are by themselves.

Some people require the reassurance that comes with having another person in the house, although not necessarily in the same room. Others require a co-sleeper to sleep peacefully.

There are several reasons why it's hard to fall asleep alone, but there are many things you can do to combat the problem. People could have trouble sleeping alone for the following reasons.

  • Fear: One of the most common reasons people cannot fall asleep when they are alone is somniphobia (fear of going to sleep). Common reasons for people having trouble sleeping include
    • People feel something will happen during the night, especially a health event or a nightmare.
    • Some people cannot stay awake or fall asleep alone and require a companion to feel relaxed.
  • Habit: Some people are habituated to sharing a bed with someone else. They may feel uncomfortable sleeping alone. Many people experience sleeplessness during their first few nights in a new home or when traveling to a foreign location. This effect is known as the “First Night Effect.”
  • Hormones: Snuggling with your loved ones can have several benefits.
    • Improves physical and mental health
    • Improves quality of sleep at night
    • Releases oxytocin, leading to a decrease in blood pressure
    • Reduces the stress hormone, cortisol, so you can get a peaceful night's sleep
    • Boosts the immune system
    • Relieves pain and anxiety
    • Elevates mood
  • Grief: Sudden loss of a loved one or a breakup can have a tremendous effect on your sleeping pattern. It can bring up an uneasy feeling of sadness that makes it difficult to fall asleep. You may have to deal with sad emotions without enough levels of the feel-good hormones to help you get through it.

What are some ways to sleep alone peacefully?

It is vital to get a good night’s sleep, whether alone or with a co-sleeper. On days when you are all alone and you’re unsure about how to sleep peacefully, use these tips.

  • Sleep with a pet dog: Experts recommend that sleeping with a pet can have the same effect as sleeping with a partner. Cuddling with a cat or dog releases oxytocin that might help one cope with the fear of sleeping alone.
  • Talk therapy: This therapy helps one identify and work through their fears. Talk therapy helps one’s body develop better sleep patterns, which can be helpful for somniphobia.
  • Practice relaxation techniques: Some of the ways you can wind down and increase your chances of sleeping alone peacefully include
    • Taking long, slow, deep breaths
    • Slowly relaxing your muscles while focusing on your breath
    • Imagining yourself in a soothing scene, place or experience in your mind to help you relax and focus
    • Practicing yoga, tai chi and qigong
  • Positive thinking: This can help combat fear and counteract bad thoughts that creep up while sleeping alone.

Are CPAP Machines Worth It? Pros and Cons

are CPAP machines worth it
Studies have shown that the benefits of CPAP machines outweigh the drawbacks when it comes to treating sleep apnea

Continuous positive airway pressure (CPAP) machines help prevent breathing interruptions that come with sleep apnea by delivering a continuous supply of oxygen to your body as you’re sleeping.

Studies have shown that the benefits of CPAP machines outweigh the drawbacks, and the benefits increase over time with long-term use. According to the National Sleep Foundation, most people who use CPAP machines report immediate symptom relief as well as improved mental alertness and energy the following day.

What are the pros and cons of CPAP machines?

Pros

Studies have shown that CPAP therapy can effectively eliminate respiratory events that interrupt sleep for those suffering from sleep apnea. Benefits of using a CPAP machine include:

  • Improved sleep cycles
  • Reduced daytime sleepiness and fatigue
  • Lowered risk of complications of sleep apnea, such as heart disease, stroke, and diabetes
  • Wide variety of machines available, based on your budget and severity of your condition
  • Reduced medical costs in the long run

Cons

Cons of using these devices may include:

  • Discomfort while using the machine, especially in the beginning
  • Nasal congestion
  • Dry mouth (since air is pushed into the mouth through the machine)
  • Eye irritation (due to increased air pressure)
  • Skin irritation (where the mask attaches to the face)
  • Bloating and gas
  • Feeling of claustrophobia
  • Partners complaining of CPAP machine noise

While many of these side effects can be annoying, they can usually be controlled by adjusting pressure settings on the CPAP machine. 

How does a CPAP machine help with sleep apnea?

People suffering from sleep apnea often suffer from breathing difficulties, stopping breathing for more than 10 seconds periodically throughout the night. This disruption in the sleep cycle can lead to sleep deprivation, which in turn can lead to serious health problems. 

CPAP machines can help normalize breathing and maintain oxygen levels during sleep. This reduces snoring, eases swelling inside the nose, and clears mucus from the airway, thus promoting better quality sleep.

CPAP machines include a mask that covers your nose and mouth, helping you breathe by increasing atmospheric pressure within the throat to stop the airway from collapsing as you inhale. By providing constant air flow, this provides a sort of barrier that prevents your throat from closing up. This mechanism also stops the tongue, uvula, and soft palate from blocking the airway.

Depending on the severity of your condition, your doctor may determine the CPAP airflow pressure settings. The machine has filters and is designed to use pressurized air from the room, which it delivers into the mask via tubes that connect to the unit. Ambient air enters through a filter and is pressurized. After it passes through a fitted, heated humidifier it is delivered to the mask through the tubing.

People diagnosed with sleep apnea often need CPAP therapy continuously throughout their lives. And since machines are not one-size-fits-all, and finding a CPAP mask that fits and feels comfortable could take a while. It’s important to talk to your doctor to determine which model is best for you.

Xywav for Narcolepsy: Side Effects, Dosage & Interactions

What is Xywav, and what is it used for?

Brand name: Xywav

Generic: calcium, magnesium, potassium, sodium oxybates

Xywav is a prescription medicine used to treat the following symptoms in people 7 years of age or older with narcolepsy:

It is not known if Xywav is safe and effective in children less than 7 years of age.

What are the side effects of Xywav?

WARNING

CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE.

Central Nervous System Depression

Xywav is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with Xywav at recommended doses. Many patients who received Xywav during clinical trials in narcolepsy were receiving central nervous system stimulants.

Abuse and Misuse

The active moiety of Xywav is oxybate or gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.

Because of the risks of CNS depression and abuse and misuse, Xywav is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Xywav and Xyrem REMS.

What are the serious side effects of Xywav?

Xywav can cause serious side effects, including:

  • breathing problems, including:
    • slower breathing.
    • trouble breathing.
    • short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take Xywav.
  • mental health problems, including:

Call your doctor right away if you have or your child has symptoms of mental health problems, or achange in weight or appetite.

  • sleepwalking. Sleepwalking can cause injuries. Call your doctor if you start or your child starts sleepwalking. Your doctor should check you or your child.

What are the common side effects of Xywav?

The most common side effects of Xywav in adults include:

The most common side effects of Xywav in children include:

These are not all the possible side effects of Xywav. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Is Xywav addictive?

Drug Abuse And Dependence

Controlled Substance

Xywav is a Schedule III controlled substance under the Federal Controlled Substances Act. Non-medical use of
Xywav could lead to penalties assessed under the higher Schedule I controls.

Abuse
  • The active moiety of Xywav, oxybate, produces dose-dependent central nervous system effects, including hypnotic and positive subjective reinforcing effects. The onset of effect is rapid, enhancing its potential for abuse or misuse.
  • Drug abuse is the intentional non-therapeutic use of a drug product or substance, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug misuse and abuse may occur with or without progression to addiction. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.
  • The rapid onset of sedation, coupled with the amnestic features of GHB, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (e.g., assault victim).
  • Illicit GHB is abused in social settings primarily by young adults. Some of the doses estimated to be abused are in a similar dosage range to that used for treatment of patients with cataplexy. GHB has some commonalities with ethanol over a limited dose range, and some cross tolerance with ethanol has been reported as well. Cases of severe dependence and craving for GHB have been reported when the drug is taken around the clock. Patterns of abuse indicative of dependence include: 1) the use of increasingly large doses, 2) increased frequency of use, and 3) continued use despite adverse consequences.
  • Because illicit use and abuse of GHB have been reported, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of GHB (e.g., increase in size or frequency of dosing, drug-seeking behavior, feigned cataplexy). Dispose of
    Xywav according to state and federal regulations. It is safe to dispose of
    Xywav down the sanitary sewer.
Dependence
  • Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. There have been case reports of withdrawal, ranging from mild to severe, following discontinuation of illicit use of GHB at frequent repeated doses (18 g to 250 g per day) in excess of the recommended dosage range.
  • Signs and symptoms of GHB withdrawal following abrupt discontinuation included insomnia, restlessness, anxiety, psychosis, lethargy, nausea, tremor, sweating, muscle cramps, tachycardia, headache, dizziness, rebound fatigue and sleepiness, confusion, and, particularly in the case of severe withdrawal, visual hallucinations, agitation, and delirium. These symptoms generally abated in 3 to 14 days.
  • In cases of severe withdrawal, hospitalization may be required. The discontinuation effects of
    Xywav have not been systematically evaluated in controlled clinical trials. In the clinical trial experience with Xyrem in narcolepsy/cataplexy patients at recommended doses, two patients reported anxiety and one reported insomnia following abrupt discontinuation at the termination of the clinical trial; in the two patients with anxiety, the frequency of cataplexy had increased markedly at the same time. In the
    Xywav clinical trial in adult narcolepsy/cataplexy patients at recommended doses, one patient reported insomnia following abrupt discontinuation of
    Xywav.

Tolerance

  • Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).
  • Tolerance to Xywav has not been systematically studied in controlled clinical trials. There have been some case reports of symptoms of tolerance developing after illicit use at dosages far in excess of the recommended
    Xywav dosage regimen.
  • Clinical studies of sodium oxybate in the treatment of alcohol withdrawal suggest a potential cross-tolerance with alcohol. The safety and effectiveness of
    Xywav in the treatment of alcohol withdrawal have not been established.




QUESTION

Why do we sleep?
See Answer

What drugs interact with Xywav?

Alcohol, Sedative Hypnotics, And CNS Depressants

Xywav is contraindicated for use in combination with alcohol or sedative
hypnotics. Use of other CNS depressants may potentiate the CNS-depressant
effects of Xywav.

Divalproex Sodium

  • Concomitant use of sodium oxybate with divalproex sodium results in an
    increase in systemic exposure to GHB, which was shown to cause a greater
    impairment on some tests of attention and working memory in a clinical
    study.
  • A similar increase in exposure is expected with concomitant use of Xywav
    and divalproex sodium; therefore, an initial dose reduction of Xywav is
    recommended when used concomitantly with divalproex sodium. Prescribers are advised to monitor patient response closely and adjust dose accordingly if concomitant use of
    Xywav and divalproex sodium is warranted.

What is the dosage for Xywav?

Adult Dosing Information

The recommended starting dosage is 4.5 grams (g) per night administered orally, divided into two doses: 2.25 g at bedtime and 2.25 g taken 2.5 to 4 hours later (see Table 1). Increase the dosage by up to 1.5 g per night per week (e.g., 0.75 g at bedtime and 0.75 g taken 2.5 to 4 hours later), to the recommended dosage range of 6 g to 9 g per night. The dosage may be gradually titrated based on efficacy and tolerability. Some patients may achieve better responses with unequal doses at bedtime and 2.5 to 4 hours later. Doses higher than 9 g per night have not been studied and ordinarily should not be administered.

Table 1: Recommended Adult Xywav Dosage Regimen (g = grams)

If a Patient’s Total Nightly Dosage Is:
Take at Bedtime:
Take 2.5 to 4 Hours Later:

4.5 g per night
2.25 g
2.25 g

6 g per night
3 g
3 g

7.5 g per night
3.75 g
3.75 g

9 g per night
4.5 g
4.5 g

Note: Some patients may achieve better responses with unequal nightly doses at bedtime and 2.5 to 4 hours later.

Pediatric Dosing Information

For pediatric patients 7 years of age and older, Xywav is administered orally twice per night. The recommended starting pediatric dosage, titration regimen, and maximum total nightly dosage are based on patient weight, as specified in Table 2. The dosage may be gradually titrated based on efficacy and tolerability. Doses higher than 9 g per night have not been studied and ordinarily should not be administered.

Table 2: Recommended Xywav Dosage for Patients 7 Years of Age and Older*

Patient Weight
Initial Dosage
Maximum Weekly Dosage Increase
Maximum Recommended Dosage

Take at Bedtime:
Take 2.5 to 4 Hours Later:
Take at Bedtime:
Take 2.5 to 4 Hours Later:
Take at Bedtime:
Take 2.5 to 4 Hours Later:

<20 kg**
There is insufficient information to provide specific dosing recommendations for patients who weigh less than 20 kg.

20 kg to <30 kg
≤1 g
≤1 g
0.5 g
0.5 g
3 g
3 g

30 kg to <45 kg
≤1.5 g
≤1.5 g
0.5 g
0.5 g
3.75 g
3.75 g

≥45 kg
≤2.25 g
≤2.25 g
0.75 g
0.75 g
4.5 g
4.5 g

* For patients who sleep more than 8 hours per night, the first nightly dose of
Xywav may be given at bedtime or after an initial period of sleep.
** If Xywav is used in patients 7 years of age and older who weigh less than 20 kg, a lower starting dosage, lower maximum weekly dosage increases, and lower total maximum nightly dosage should be considered.
Note: Some patients may achieve better responses with unequal nightly doses at bedtime and 2.5 to 4 hours later.

Important Administration Instructions For All Patients

  • The total nightly dosage of Xywav is divided into two doses. Prepare both doses of
    Xywav prior to bedtime. Prior to ingestion, each dose of Xywav should be diluted with approximately ¼ cup (approximately 60 mL) of water in the empty pharmacy containers provided. Solutions prepared following dilution should be consumed within 24 hours.
  • Take the first nightly dose of Xywav at least 2 hours after eating. Take
    the second nightly dose 2.5 to 4 hours after the first dose.
  • Patients should take each dose of Xywav while in bed and lie down
    immediately after dosing, and remain in bed following ingestion of each
    dose. Xywav may cause patients to fall asleep abruptly without first feeling
    drowsy.
  • Patients will often fall asleep within 5 minutes of taking Xywav, and will usually fall asleep within 15 minutes, though the time it takes any individual patient to fall asleep may vary from night to night.
  • Patients may need to set an alarm to awaken for the second dose. If the second dose is missed, that dose should be skipped and
    Xywav should not be taken again until the next night. Two Xywav doses should never be taken at one time.

Patients Transitioning From Xyrem To Xywav

  • On the first night of dosing with Xywav, initiate treatment at the same
    dose (gram for gram) and regimen as Xyrem. Titrate as needed based on
    efficacy and tolerability.

Dosage Modification In Patients With Hepatic Impairment

  • The recommended starting dosage in patients with hepatic impairment is
    one-half of the original dosage per night administered orally, divided into
    two doses.

Dosage Adjustment With Co-Administration Of Divalproex Sodium

  • When initiating divalproex sodium in patients taking a stable dosage of
    Xywav, a reduction of the Xywav dosage by at least 20% is recommended with
    initial concomitant use. When initiating Xywav in patients already taking divalproex sodium, a lower starting dosage of
    Xywav is recommended. Subsequently, the dosage of Xywav can be adjusted based on individual clinical response and tolerability.

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Xywav contraindications, and pregnancy and breastfeeding safety

Do not take Xywav if you or your child:

  • takes other sleep medicines or sedatives (medicines that cause sleepiness)
  • drinks alcohol
  • has a rare problem called succinic semialdehyde dehydrogenase deficiency

Before taking Xywav, tell your doctor about all medical conditions, including if you or your child:

  • have a history of drug abuse.
  • have short periods of not breathing while sleeping (sleep apnea).
  • has trouble breathing or has lung problems. You or your child may have a higher chance of having serious breathing problems when taking
    Xywav.
  • have or had depression or has tried to harm yourself or themselves. You or your child should be watched carefully for new symptoms of depression.
  • has or had behavior or other psychiatric problems such as:
    • anxiety
    • seeing or hearing things that are not real (hallucinations)
    • feeling more suspicious (paranoia)
    • being out of touch with reality (psychosis)
    • acting aggressive
    • agitation
  • have liver problems.
  • are pregnant or plan to become pregnant. It is not known if Xywav can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Xywav passes into breast milk. You and your doctor should decide if you or your child will take
    Xywav or breastfeed.

Tell your doctor about all the medicines you take or your child takes, including prescription and over-thecounter medicines, vitamins, and herbal supplements.

Especially, tell your doctor if you take or your child takes other medicines to help you or your child sleep (sedatives). Know the medicines you take or your child takes. Keep a list of them to show your doctor and pharmacist when you get or your child gets a new medicine.

What Causes Night Terrors? How They Differ to Nightmares

night terrors causes
Night terrors may result from a variety of factors, such as sleep deprivation, extreme tiredness, anxiety and certain medications.

Night terrors are a disorder of arousal and occur during the deepest stage of sleep, which is the stage NIII of non-rapid eye movement (NREM) sleep. Various factors can cause night terrors, such as:

  • Overtired children
  • Sleep deprivation
  • Change in sleep schedule, travel, jet lag
  • Fever
  • Stress
  • Anxiety
  • Traumatic events
  • Certain medications
  • Having a fear of something
  • Alcohol

What are night terrors?

Night terrors, also called sleep terrors, are often confused with nightmares. However, they are very different from each other.

Night terrors are present as episodes of intense fear, screaming and flailing (moving without control) while still being asleep, and are often associated with sleepwalking. They are considered a form of parasomnia (a sleep disorder that involves unusual and unwanted physical events or experiences that can disrupt sleep). Episodes of night terrors usually last a few seconds to minutes, though they sometimes may last longer.

Sleep terrors are more common in children (affecting almost 40 percent of children) and occasionally can affect adults as well. Most children outgrow them by the time they become a teenager. Furthermore, they may not be able to recall their night terrors when they are fully awake.

Night terrors require treatment if they are affecting the person’s quality of sleep or pose a safety risk.

How do night terrors differ from nightmares?

Nightmares are vividly realistic, disturbing dreams that can disturb sleep, create fear and even cause palpitations and rapid breathing. Nightmares tend to occur most often during rapid eye movement sleep or REM sleep, which most dreams occur during this stage. Because periods of REM sleep become progressively longer as the night progresses, nightmares are more common in the early morning hours.

The subjects of nightmares can vary with people. However, there are some common themes that many people experience. For example, not being able to run fast enough to escape danger, falling off a cliff, teeth falling out, etc. Recurrent nightmares may occur following a traumatic event, such as an attack or accident.

Nightmares and night terrors both cause disturbed sleep and awaken people in fear. However, they are different. Night terrors usually occur in the first few hours after falling asleep. They are experienced as feelings and not dreams. Generally, people do not recall their night terror and why they are terrified on awakening, but people may be able to recall nightmares.

Nightmares and night terrors can occur in adults and children, with night terrors more common in the latter. Chronic, recurrent nightmares can result in poor quality sleep and affect mental and overall health.

What are the treatments for night terrors in adults?

Nightmares and night terrors caused by other medical conditions or medications usually stop when the condition is treated or the medications are discontinued. Psychological conditions may require treatment with medication and psychotherapy. They are effective in most cases, including those who have depression, anxiety or post-traumatic stress disorder (PTSD). Lifestyle changes, such as keeping a regular sleep-wake schedule, regular exercise, practicing yoga and meditation and stress management can help reduce and prevent night terrors.

What is the treatment for night terrors in children?

The following ways may help reduce the frequency or stop night terrors and nightmares in children:

  • Making sure the child gets enough sleep
  • Keeping the bedtime routine light and happy
  • Talking about the nightmare during the day
  • Comforting and reassuring the child
  • Encouraging the child to go back to sleep in their own bed
  • Avoiding keeping bright lights on in the bedroom, but a night light may be used to give the child comfort
  • Leaving the bedroom door open, so they feel safe and close to the parents
  • Seeking the help of a doctor or child counselor to help address the underlying cause and help the child overcome nightmares and the associated distress

Somnambulism: Causes & Treatment for Sleepwalking

Sleepwalk (Somnambulism)
Somnambulism (also known as sleepwalking) is a parasomnia that can result from these various causes and factors.

Somnambulism is a common parasomnia (abnormal behavior in sleep) consisting of a series of complex behaviors that result in large movements in bed or walking during sleep.

Sleepwalking is a disorder of arousal, meaning it occurs during the deepest stages of non-rapid eye movement (NREM) sleep. Another NREM disorder is sleep terrors, which can occur in tandem with sleepwalking.

Many factors can contribute to sleepwalking, including:

While most frequent in children (2 to 14 percent), sleepwalking is typically a benign, self-limited maturational occurrence and often decreases with the onset of puberty. However, at least 25 percent of children with recurrent sleepwalking may continue the disorder into adulthood. Chronic sleepwalking in children is often associated with other subtle sleep disorders, behavioral problems and poor emotional regulation.

Sometimes, sleepwalking can be triggered by underlying conditions that interfere with sleep, such as:

What are the signs and symptoms of somnambulism?

In addition to physically getting out of bed and walking around, sleepwalkers may exhibit other symptoms, such as:

  • Sitting up in bed and repeating movements, such as rubbing eyes or tugging on pajamas
  • Looking dazed (the sleepwalkers’ eyes are open but do not look the same way as when they are fully awake)
  • Clumsy or awkward behavior
  • Not responding when spoken to or giving senseless responses
  • Difficulty waking up
  • Talking in their sleep
  • Urinating in undesirable places (for instance a closet)

Diagnosis

Sleepwalking is usually simple to diagnose. Your healthcare professional will ask about your symptoms and medical history. They may even suggest some tests to find out whether a medical condition is causing sleepwalk, which may include:

  • Physical exam
  • Polysomnography (sleep study)
  • Electroencephalography (EEG)

How is somnambulism treated?

Treatment for occasional sleepwalking usually isn't necessary. In children who sleepwalk, it typically goes away by their teen years.

If sleepwalking leads to the potential for injury, is disruptive to family members or results in embarrassment or sleep disruption, treatment may be needed. Treatment generally focuses on promoting safety and eliminating causes or triggers.

Treatment for somnambulism may include:

  • Treating any underlying condition: if the sleepwalking is associated with sleep deprivation or an underlying sleep disorder or medical condition.
  • Anticipatory awakenings: such as waking the person up about 15 minutes before they usually sleepwalk, and then staying awake for a few minutes before they fall back asleep again.
  • Medications: such as benzodiazepines or certain antidepressants.
  • Learning self-hypnosis: performed by a trained professional who is familiar with parasomnias. People who are receptive to suggestions during hypnosis may benefit by achieving a deep state of relaxation, which promotes a change in unwanted activities during sleep.
  • Therapy or counseling: a mental health professional can help with suggestions for improving sleep, stress-reduction techniques, self-hypnosis and relaxation.

Wakix (pitolisant)

What is Wakix, and how does it work?

Wakix is indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

What are the side effects of Wakix?

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • QT Interval Prolongation

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the clinical trials for narcolepsy, 172 patients were treated with Wakix in placebo-controlled trials for up to 8 weeks and in open-label extension trials for up to 5 years. In trials in which pitolisant was directly compared to placebo, 6 of the 152 patients (3.9%) who received Wakix and 4 of the 114 patients (3.5%) who received placebo discontinued because of an adverse event.

Most Common Adverse Reactions

In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (occurring in ≥5% of patients and at twice the rate of placebo) with the use of Wakix were

Table 1 presents the adverse reactions that occurred at a rate of ≥2% in patients treated with Wakix and more frequently than in patients treated with placebo in the placebo-controlled clinical trials in narcolepsy.

Table 1: Adverse Reactions that Occurred in ≥2% of Wakix-Treated Patients and More Frequently than in Placebo-Treated Patients in Three Placebo-controlled Narcolepsy Studies

Adverse ReactionWakix
(n=152) %Placebo
(n=114) %Headache*1815Insomnia*62Nausea63Upper respiratory tract infection*53Musculoskeletal pain*53Anxiety*51Heart rate increased*30Hallucinations*30Irritability32Abdominal pain*31Sleep disturbance*32Decreased appetite30Cataplexy21Dry mouth21Rash*21* The following terms were combined:
Abdominal pain includes: abdominal discomfort; abdominal pain; abdominal pain upper
Anxiety includes: anxiety; nervousness; stress; stress at work
Hallucinations includes: hallucination; hallucination visual; hypnagogic hallucination
Headache includes: cluster headache; headache; migraine; premenstrual headache; tension headache
Heart rate increased includes: heart rate increased; sinus tachycardia; tachycardia
Insomnia includes: initial insomnia; insomnia; middle insomnia; poor quality sleep
Musculoskeletal pain includes: arthralgia; back pain; carpal tunnel syndrome; limb discomfort; musculoskeletal pain; myalgia; neck pain; osteoarthritis; pain in extremity; sciatica
Sleep disturbance includes: dyssomnia; sleep disorder; sleep paralysis; sleep talking
Rash includes: eczema, erythema migrans, rash, urticaria
Upper respiratory infection includes: pharyngitis; rhinitis; sinusitis; upper respiratory tract infection; upper respiratory tract inflammation; viral upper respiratory tract infection

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Wakix outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

What is the dosage for Wakix?

Recommended Dosage

The recommended dosage range for Wakix is 17.8 mg to 35.6
mg administered orally once daily in the morning upon wakening. Titrate dosage
as follows:

  • Week 1: Initiate with a dosage of 8.9 mg (two 4.45 mg
    tablets) once daily
  • Week 2: Increase dosage to 17.8 mg (one 17.8 mg tablet)
    once daily
  • Week 3: May increase to the maximum recommended dosage of
    35.6 mg (two 17.8 mg tablets) once daily
  • Dose may be adjusted based on tolerability.
  • If a dose is missed, patients should take the next dose
    the following day in the morning upon wakening.
  • It may take up to 8 weeks for some patients to achieve a
    clinical response.

Dosage Modification And Recommendations In Patients With Hepatic
Impairment

  • In patients with moderate hepatic impairment, initiate Wakix at 8.9 mg
    once daily and increase after 14 days to a maximum dosage of 17.8 mg once
    daily.
  • Wakix is contraindicated in patients with severe hepatic impairment.
    Wakix has not been studied in patients with severe hepatic impairment.

Dosage Modification And Recommendations In Patients With Renal
Impairment And End Stage Renal Disease

  • In patients with moderate and severe renal impairment, initiate Wakix at
    8.9 mg once daily and increase after 7 days to a maximum dosage of 17.8 mg
    once daily.
  • Wakix is not recommended in patients with end stage renal disease
    (ESRD).

Dosage Recommendations For Concomitant Use With Strong
CYP2D6 Inhibitors And Strong CYP3A4 Inducers

Coadministration With Strong CYP2D6 Inhibitors
  • For patients receiving strong CYP2D6 inhibitors, initiate
    Wakix at 8.9 mg once daily and increase after 7 days to a maximum dosage of
    17.8 mg once daily.
  • For patients on a stable dose of Wakix, reduce the Wakix dose by half
    upon initiating strong CYP2D6 inhibitors.
Coadministration With Strong CYP3A4 Inducers
  • Concomitant use of Wakix with strong CYP3A4 inducers
    decreases pitolisant exposure by 50%. Assess for loss of efficacy after
    initiation of a strong CYP3A4 inducer.
  • For patients stable on Wakix 8.9 mg or 17.8 mg once
    daily, increase the dose of Wakix to double the original daily dose (i.e., 17.8
    mg or 35.6 mg, respectively) over 7 days.
  • If concomitant dosing of a strong CYP3A4 inducer is discontinued,
    decrease Wakix dosage by half.

Use In Patients Who Are Known CYP2D6 Poor Metabolizers
(PMs)

  • In patients known to be poor CYP2D6 metabolizers, initiate Wakix at 8.9
    mg once daily and titrate to a maximum dose of 17.8 mg once daily after 7
    days.





QUESTION

Why do we sleep?
See Answer

What drugs interact with Wakix?

Drugs Having Clinically Important Interactions With Wakix

Table 2: Clinically Significant Drug Interactions with
Wakix

Effect of Other Drugs on Wakix

Strong CYP2D6 Inhibitors

Clinical Implication:
Concomitant administration of Wakix with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold.

Prevention or Management:
Reduce the dose of Wakix by half.

Examples:
paroxetine, fluoxetine, bupropion

Strong CYP3A4 Inducers

Clinical Implication:
Concomitant use of Wakix with strong CYP3A4 inducers decreases exposure of pitolisant by 50%.

Prevention or Management:
Assess for loss of efficacy after initiation of a strong CYP3A4 inducer.
For patients stable on Wakix 8.9 mg or 17.8 mg once daily, increase the dose
of Wakix to reach double the original daily dose (i.e., 17.8 mg or 35.6 mg,
respectively) over 7 days. If concomitant dosing of a strong CYP3A4 inducer
is discontinued, decrease Wakix dosage by half.

Examples:
rifampin, carbamazepine, phenytoin

Histamine-1 (H1) Receptor Antagonists

Clinical Implication:
Wakix increases the levels of histamine in the brain; therefore, H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of
Wakix.

Prevention or Management:
Avoid centrally acting H1 receptor antagonists.

Examples:
pheniramine maleate, diphenhydramine, promethazine (anti-histamines) imipramine, clomipramine, mirtazapine (tri or tetracyclic antidepressants)

QT Interval Prolongation

Clinical Implication:
Concomitant use of drugs that prolong the QT interval may add to the QT effects of
Wakix and increase the risk of cardiac arrhythmia.

Prevention or Management:
Avoid the use of Wakix in combination with other drugs known to prolong
the QT interval.

Examples:
Class 1A antiarrhythmics: quinidine, procainamide, disopyramide; Class 3 antiarrhythmics: amiodarone, sotalol; Antipsychotics: ziprasidone, chlorpromazine, thioridazine; Antibiotics: moxifloxacin

Effect of Wakix on Other Drugs

Sensitive CYP3A4 Substrates

Clinical Implication:
Wakix is a borderline/weak inducer of CYP3A4. Therefore, reduced
effectiveness of sensitive CYP3A4 substrates may occur when used
concomitantly with Wakix.

 
The effectiveness of hormonal contraceptives (e.g., ethinyl estradiol) may be reduced when used with
Wakix and effectiveness may be reduced for 21 days after discontinuation of therapy.

Prevention or Management:
Patients using hormonal contraception should be advised to use an
alternative non-hormonal contraceptive method during treatment with Wakix
and for at least 21 days after discontinuation of treatment.

Examples:
midazolam, hormonal contraceptives, cyclosporine

Drugs Having No Clinically Important Interactions With Wakix

A clinical study was conducted to evaluate the concomitant use of Wakix with
modafinil or sodium oxybate. This study demonstrated no clinically relevant
effect of modafinil or sodium oxybate on the pharmacokinetics of Wakix and no
effect of Wakix on the pharmacokinetics of modafinil or sodium oxybate.

A clinical study showed that strong CYP3A4 inhibitors (e.g., ketoconazole,
grapefruit juice) have no effect on the pharmacokinetics of Wakix.

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Is Wakix safe to use while pregnant or breastfeeding?

  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to
    Wakix during pregnancy.
  • Patients should be encouraged to enroll in the Wakix pregnancy registry if they become pregnant.
  • To enroll or obtain information from the registry, patients can call 1-800-833-7460.
  • There are no data on the presence of pitolisant in human milk, the effects on the breastfed infant, or the effect of this drug on milk production.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for
    Wakix and any potential adverse effects on the breastfed child from Wakix or from the underlying maternal condition.

ramelteon (Rozerem) Uses, Side Effects & Dosage

What is Rozerem, and how does it work (mechanism of action)?

Ramelteon is an oral drug that promotes
falling asleep and is used for treating insomnia. It acts by stimulating
receptors for melatonin in the brain. Melatonin and its receptors control the
circadian rhythm of the body which controls the sleep/wake cycle. Unlike many
drugs used for treating insomnia, ramelteon is not addictive, and it is not a
controlled substance. Ramelteon also does not cause withdrawal symptoms or
rebound insomnia when it is stopped. Ramelteon was approved by the FDA in July
1995.

What brand names are available for Rozerem?

Rozerem

Is Rozerem available as a generic drug?

No.

Do I need a prescription for Rozerem?

Yes.

What are the side effects of Rozerem?

Side effects associated with ramelteon include:

Rare cases of severe allergic reactions involving swelling of the tongue and
closure of the throat have been reported.

Other important side effects include:

What is the dosage for Rozerem?

The recommended dose of ramelteon is 8 mg taken 30 minutes
before bedtime. Ramelteon should not be taken with or immediately after a high
fat meal because fat increases its absorption from the intestine.




QUESTION

What is insomnia?
See Answer

Which drugs or supplements interact with Rozerem?

Doxepin
(Sinequan, Adapin), donepezil (Aricept),

fluvoxamine (Luvox, Luvox CR),
ketoconazole
(Nizoral, Extina, Xolegel, Kuric), and fluconazole (Sporanox) increase blood levels of ramelteon,
possibly increasing side effects of ramelteon. Rifampin may decrease blood
levels of ramelteon, possibly reducing the effect of ramelteon. Alcohol
increases the sedative effects ramelteon.

Is Rozerem safe to take if I’m pregnant or breastfeeding?

Ramelteon has not been evaluated in
pregnant women. Animal
studies show that it may cause harm. Therefore, ramelteon should not be used in
pregnant women unless it is absolutely necessary.

Ramelteon has not been evaluated in
nursing mothers.

What else should I know about Rozerem?

What preparations of Rozerem are available?

How should I keep Rozerem stored?

Ramelteon should be store at room temperature, between 15 C – 30 C (59 F – 86 F).