What is WAKIX?
WAKIX® (pitolisant) is a first-of-its-kind medication that increases histamine levels in the brain.
- The way WAKIX works to treat excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy is not fully understood.
WAKIX is the first and only once-daily tablet that is FDA approved to treat EDS or cataplexy in adults with narcolepsy.
WAKIX is the first and only FDA-approved treatment for people with narcolepsy that is not a controlled substance.
WAKIX is not a stimulant.
How Does WAKIX Work?
The way that WAKIX works to treat EDS or cataplexy in adults with narcolepsy is not fully understood. It is thought that WAKIX works due to how it affects histamine. WAKIX increases histamine levels in the brain. Watch this short video to learn how WAKIX is thought to work.
What does histamine do in the brain?
Histamine is a natural chemical in the brain that helps us to stay awake and have stable muscle tone throughout the day.
Can I take antihistamines if I'm taking WAKIX?
Some antihistamines can prevent histamine from working in the brain. These medications may reduce the effectiveness of WAKIX and should be avoided.
Tell your healthcare provider about all the medicines you take or plan to take, including prescription or over-the-counter medicines. Your healthcare provider may be able to provide suggestions about what antihistamines or alternative treatments can be taken with WAKIX.
WAKIX personal stories
Hear the personal stories of real people living with narcolepsy. Each person has their own story to tell, from diagnosis to finding support, and their experience with WAKIX.Watch more
Indications and usage & Important Safety Information
Important Safety Information
Do not take WAKIX if you are allergic to pitolisant or any ingredient in WAKIX, or if you have severe liver disease.
Tell your healthcare provider about all your medical conditions, including if you have heart rhythm irregularities, were born with a heart condition, or the levels of electrolytes in your blood are too high or too low. WAKIX has an effect on the electrical activity of the heart known as QT/QTc prolongation. Medicines with this effect can lead to disturbances in heart rhythm, which are more likely in patients with risk factors such as certain heart conditions, or when taken in combination with other medicines that affect QT. Tell your healthcare provider about all the other medicines you take.
The risk of QT prolongation may be greater in patients with liver or kidney disease. WAKIX is not recommended in patients with end-stage kidney disease.
The most common side effects seen with WAKIX were insomnia, nausea, and anxiety. Other side effects included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, and decreased appetite. These are not all the possible side effects of WAKIX. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines. Some medicines can increase the amount of WAKIX that gets into your blood and some medicines can decrease the amount of WAKIX that gets into your blood. The dosage of WAKIX may need to be adjusted if you are taking these medicines.
WAKIX can also decrease the effectiveness of some medicines, including hormonal birth control methods. You should use an alternative non-hormonal birth control method during treatment with WAKIX and for at least 21 days after discontinuation of treatment.
Tell your healthcare provider if you are pregnant or planning to become pregnant. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. You are encouraged to enroll in the WAKIX pregnancy registry if you become pregnant while taking WAKIX. To enroll or obtain information from the registry, call 1-800-833-7460.
The safety and effectiveness of WAKIX have not been established in patients less than 18 years of age.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You can also report negative side effects to Harmony Biosciences at 1-800-833-7460.
Please see Full Prescribing Information.
Indications and Usage
WAKIX is a prescription medicine used to treat excessive daytime sleepiness (EDS) or sudden onset of weak or paralyzed muscles (cataplexy) in adults with narcolepsy.
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