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Wakix Approval History

Reviewed by J.Stewart BPharm Last updated on Aug 31, 2019.

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) 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.
  • Patients should tell their healthcare provider about all the medicines they take, or plan to take, including prescription and over-the-counter medicines, as there may be interactions between Wakix and other drugs.
  • 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.
  • The most common side effects seen with Wakix were insomnia, nausea and anxiety.

Development History and FDA Approval Process for Wakix

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.