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What is Wakix, and how does it work?
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
|Upper respiratory tract infection*||5||3|
|Heart rate increased*||3||0|
|* 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
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:
- General disorders and administration site conditions: fatigue
- Investigations: weight increased
- Nervous system disorders: epilepsy
- Psychiatric disorders: abnormal behavior, abnormal dreams, anhedonia, bipolar disorder, depression, depressed mood, nightmare, sleep disorder, suicide attempt, suicidal ideation
- Skin and subcutaneous tissue disorders: pruritus
What is the dosage for Wakix?
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.
What drugs interact with Wakix?
Drugs Having Clinically Important Interactions With Wakix
Table 2: Clinically Significant Drug Interactions with
|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.
Wakix is indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. The most common adverse reactions with the use of Wakix were insomnia, nausea, and anxiety.
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Sleep: A Dynamic Activity
Second Source article from Government
Sleep apnea is defined as a reduction or cessation of breathing during sleep. The three types of sleep apnea are central apnea, obstructive apnea (OSA), and a mixture of central and obstructive apnea. Central sleep apnea is caused by a failure of the brain to activate the muscles of breathing during sleep. OSA is caused by the collapse of the airway during sleep. OSA is diagnosed and evaluated through patient history, physical examination and polysomnography. There are many complications related to obstructive sleep apnea. Treatments are surgical and non-surgical.
Sleep Disorders (How to Get a Good Night's Sleep)
A number of vital tasks carried out during sleep help maintain good health and enable people to function at their best. Sleep needs vary from individual to individual and change throughout your life. The National Institutes of Health recommend about 7-9 hours of sleep each night for older, school-aged children, teens, and most average adults; 10-12 for preschool-aged children; and 16-18 hours for newborns. There are two stages of sleep; 1) REM sleep (rapid-eye movement), and 2) NREM sleep (non-rapid-eye movement). The side effects of lack of sleep or insomnia include: Irritability Tiredness Feeling sleepy during the day Concentration or memory problems Lack of sleep and insomnia can be caused by medical conditions or diseases, medications, stress, or pain. The treatment for lack of sleep and insomnia depends upon the cause.
Insomnia Treatment (Sleep Aids and Stimulants)
Insomnia is difficulty in falling or staying asleep, the absence of restful sleep, or poor quality of sleep. Insomnia is a symptom and not a disease. The most common causes of insomnia are medications, psychological conditions, environmental changes and stressful events. Treatments may include non-drug treatments, over-the-counter medicines, and/or prescription medications.
Narcolepsy (Definition, Symptoms, Treatment, Medication)
Causes of narcolepsy, a chronic disease of the central nervous system, have not been fully determined. Some theories include abnormalities in hypocretin neurons in the brain or an autoimmune disorder. Symptoms of narcolepsy include: excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, disturbed nocturnal sleep, and automatic behavior. Diagnosis of narcolepsy is based on a clinical evaluation, specific questionnaires, sleep logs or diaries, and the results of sleep laboratory tests. Treatments of narcolepsy symptoms include medication and lifestyle changes.
Sleepwalking (Causes, Symptoms, Treatment)
Sleepwalking is a condition in which an individual walks or does other activities while asleep. Factors associated with sleepwalking include genetic, environmental, and physiological. Episodes of sleepwalking may include quiet walking to agitated running. Conditions that may have similar symptoms of sleepwalking, but are not include night terrors, confusional arousals, and nocturnal seizures. Treatment of sleepwalking generally include preventative measures. Medication may be prescribed if necessary.
Sleep Related Breathing Disorders
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Sleep and Sleep Disorders in Children and Teenagers
Sleep needs in children and teenagers depend on the age of the child. Sleep disorders in children such as: sleep apnea, parasomnias, confusional arousals, night terrors, nightmares, narcolepsy, and sleepwalking which can affect a child's or teen's sleep. Healthy sleep habits and good sleep hygiene can help your infant, toddler, preschooler, tween, or teenager get a good night's sleep.
Sleep paralysis is a condition that causes a person to feel as if he or she is awake but is unable to move. Lack of sleep, sleep disorders, use of certain medications, and other factors may be related to sleep paralysis. Sleep paralysis usually does not require treatment; however, treating underlying conditions may help sleep paralysis.
What Are the Warning Signs of Sleep Apnea?
Sleep apnea is a serious sleep disorder in which an individual’s breathing frequently stops during sleep. The inadequate breathing causes oxygen levels in the blood to drop and disturb sleep.
Do You Hallucinate During Sleep Paralysis?
Some people may experience hallucinations during sleep paralysis. The hallucinations may last from a few seconds to a few minutes.
What Are the Five Signs of Narcolepsy?
Narcolepsy is a neurological disorder that affects your ability to sleep and wake up. People with narcolepsy have excessive, uncontrollable daytime sleepiness.
Why Am I Having Trouble Sleeping at Night?
Having repeated difficulty with sleep initiation, maintenance or poor quality of sleep that occurs despite adequate time and opportunity for sleep, resulting in some form of daytime impairment is called insomnia.
What Are the Warning Signs of Sleep Apnea?
Sleep apnea is a sleep disorder that can potentially lead to serious systemic health complications. It is a condition that causes a person to intermittently stop breathing during sleep. Warning signs of sleep apnea include snoring, nighttime gasping, intermittent pauses during sleep, and daytime sleepiness.
What Are the Three Types of Sleep Apnea?
Sleep apnea is a sleep disorder that can potentially lead to serious health complications. In sleep apnea, the person may stop breathing for some time during sleep. The three kinds of sleep apnea are obstructive sleep apnea, central sleep apnea, and mixed sleep apnea.
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