Wakix FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 28, 2020.
FDA Approved: Yes (First approved August 14, 2019)
Brand name: Wakix
Generic name: pitolisant
Dosage form: Tablets
Company: Harmony Biosciences, LLC
Treatment for: Narcolepsy
Wakix (pitolisant) is a histamine-3 (H₃) receptor antagonist/inverse agonist for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.
Wakix is taken once daily in the morning upon wakening.
IMPORTANT SAFETY INFORMATION
- Wakix should not be used in patients with severe liver disease.
- Patients should tell their healthcare provider about all their medical conditions, including heart rhythm irregularities, congenital heart conditions, and abnormal levels of electrolytes. They should contact their healthcare provider immediately if they feel faint, lose consciousness, or have heart palpitations.
- 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.
- Wakix can decrease the effectiveness of some medicines, including hormonal birth control methods. Patients should use an alternative non-hormonal birth control method during treatment with Wakix and for at least 21 days after discontinuation of treatment.
- Patients should tell their healthcare provider if they 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.
- Common side effects include insomnia, nausea and anxiety.
Development timeline for Wakix
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.