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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.


  • 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

Oct 13, 2020Approval Harmony Biosciences Receives FDA Approval for Expanded Use of Wakix (pitolisant) for the Treatment Of Cataplexy in Adult Patients with Narcolepsy
Aug 15, 2019Approval FDA Approves Wakix (pitolisant), a First-in-Class Medication for the Treatment of Excessive Daytime Sleepiness in Adult Patients with Narcolepsy
Feb 12, 2019Harmony Biosciences Announces File Acceptance Of Its New Drug Application For Pitolisant
Sep 11, 2018Harmony Biosciences Presents 5-Year Data On Pitolisant At International Narcolepsy Symposium

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.