Wakix is a prescription medication approved by the FDA to treat symptoms of narcolepsy in adults. It contains the active ingredient pitolisant and is available in tablet form. Unlike other treatments for sleep disorders, Wakix does not work as a stimulant. It is instead classified as a histamine-3 (H3) receptor antagonist/inverse agonist.
Although Wakix is an effective medication, it’s important to consult a healthcare professional about the appropriate dosage and potential safety concerns. Wakix may be associated with side effects and should be used with caution in people with kidney or liver disease.
Wakix overview
BRAND NAMES:
Wakix
Generic Names:
Pitolisant
Uses:
Treats:
Sudden onset of weak or paralyzed muscles
Therapeutic Classes:
Central nervous system agent
Forms:
Tablet
How it’s taken:
By mouth
What is Wakix used for?
Wakix is used for the treatment of excessive daytime sleepiness (EDS) and sudden muscle weakness (cataplexy) in people with narcolepsy. It has a unique mechanism of action that differs from typical treatments for narcolepsy. It effectively targets histamine-3 receptors in the brain to increase histamine levels, which can help promote wakefulness.
Key takeaways
Wakix is mainly used to treat narcolepsy, a condition that causes excessive daytime sleepiness and sudden muscle weakness. While Wakix can help manage these symptoms, it is not a cure for narcolepsy.
Always take Wakix exactly as prescribed by your doctor. Don’t adjust the dose or frequency without consulting your healthcare provider. Taking the correct dosage ensures the maximum benefits while reducing the potential side effects of Wakix.
Like all medications, Wakix may cause side effects. Common ones include insomnia, nausea, and anxiety. If you experience any adverse reactions or effects, especially if they are severe or don’t go away, inform your doctor.
Wakix can interact with other drugs, including over-the-counter medications and supplements. Tell your healthcare provider about all the medications you are taking to avoid potential interactions that may be harmful.
Pay attention to any changes in your health while taking Wakix, especially related to heart rate and rhythm. If you have existing health conditions like liver disease or heart problems, discuss these with your doctor.
What form(s) does Wakix come in
Tablet
4.45 mg
17.8 mg
What are common Wakix doses?
The standard Wakix dosage is 17.8 to 35.6 mg per day for most individuals. Wakix is typically started at a low dosage that is gradually increased as follows:
8.9 mg (two 4.45 mg tablets) once daily during the first week
17.8 mg (one 17.8 mg tablet) once daily during the second week
Dosage may be increased to 35.6 mg once daily during the third week
For individuals with liver problems, the typical starting dosage is 8.9 mg once daily. The dosage may be increased to a maximum of 17.8 mg once daily after two weeks.
The typical starting dosage for individuals with kidney problems is 8.9 mg once daily. The dosage may be increased to a maximum of 17.8 mg once daily after one week.
For people who are poor metabolizers of a liver enzyme called CYP2D6, the maximum dosage is 17.8 mg once daily.
How to take Wakix
Take your medicine as directed. Your dose may need to be adjusted based on how effective the medication is and whether you experience side effects.
Swallow the tablet whole. Do not crush, break, or chew it.
Take the tablet when you wake up in the morning.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
Consult your healthcare provider for medical advice and further usage instructions; never use more than directed or prescribed.
What to do if you miss a dose of Wakix
If you missed a dose, take the next dose the following day when you first wake up in the morning.
Wakix contraindications
Do not use Wakix if you have had an allergic reaction to pitolisant or any of the ingredients in the medication.
Do not use Wakix if you have severe hepatic impairment or liver disease.
Wakix warnings
Tell your doctor if you are pregnant or breastfeeding, and discuss the potential risks and benefits of taking Wakix with your healthcare provider.
Consult your doctor if you have kidney disease, liver disease, or have had heart rhythm problems (including arrhythmia and slow heartbeat) before starting treatment.
This medicine may cause heart rhythm problems, including QT prolongation.
Your doctor may recommend lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
Inform your healthcare provider about all other medications you're currently taking, including prescription drugs, over-the-counter medicines, and herbal supplements, as certain drugs may have interactions with Wakix.
Keep all medicine out of the reach of children. Never share your medicine with anyone.
Wakix interactions
Birth control pills may not be as effective while you are using pitolisant. To keep from getting pregnant, use another form of birth control during treatment and for at least 21 days after your last dose. Your healthcare provider may recommend other forms of birth control, such as condoms, diaphragms, or contraceptive foams or gels.
Some medicines can affect how pitolisant works. Most of the interactions involve interfering with the metabolism of the medication in the liver. Tell your doctor if you are using any of the following:
Carbamazepine
Cyclosporine
Midazolam
Moxifloxacin
Phenytoin
Rifampin
Medicine to treat allergies (including diphenhydramine, pheniramine maleate, promethazine)
Medicine to treat depression (including bupropion, clomipramine, fluoxetine, imipramine, mirtazapine, paroxetine)
Medicine to treat heart rhythm problems (including amiodarone, disopyramide, procainamide, quinidine, sotalol)
Medicine to treat mental illness (including chlorpromazine, thioridazine, ziprasidone)
This may not be a complete list of drug interactions. Consult a healthcare provider for other possible interactions associated with the use of Wakix.
Wakix side effects
Despite its benefits in promoting wakefulness, Wakix may also cause some side effects. These side effects can vary in severity and frequency; not every individual will experience the same effects.
Serious side effects:
Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
Fast, pounding, or uneven heartbeat
Seizures
Suicidal thoughts or behavior
Less serious side effects:
Trouble sleeping
Headache
Nausea
Anxiety
Decreased appetite
Dry mouth
Stomach pain
Seek medical help if any serious side effects develop. Get emergency medical attention if you experience symptoms of an allergic reaction like hives, swelling of the face or throat, or breathing problems.
Sources:
Narcolepsy, National Institute of Neurological Disorders and Stroke (2023)
Highlights of prescribing information, Food and Drug Administration (2022)
Pitolisant to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy: Rationale and clinical utility, Nature and Science of Sleep (2020)
Pitolisant, National Library of Medicine (2021)
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