Wakix
Wakix ingredients
| Active ingredient | Strength |
|---|---|
| Pitolisant Hydrochloride | 4.45 mg/1, 17.8 mg/1 |
What Wakix is used for
The FDA lists the approved uses on the official label (below). In the EU, pitolisant is approved as Wakix for:
Wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.1).
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Wakix
- Generic name
- Pitolisant hydrochloride
- Made by
- Harmony Biosciences, LLC
- Forms
- Tablet, Film Coated
- Given
- Oral
- Drug class
- Histamine-3 Receptor Antagonist/Inverse Agonist
- FDA approval
- New drug application (NDA) NDA211150
- On the US market since
- 2019
Official information
- Wakix prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Pitolisant hydrochloride)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Wakix?
Wakix (Pitolisant hydrochloride) is a specialist medicine made by Harmony Biosciences, LLC, approved by the US FDA.
What are the ingredients of Wakix?
Wakix contains Pitolisant Hydrochloride (4.45 mg/1, 17.8 mg/1).
Is Wakix approved in Europe?
The same active substance is approved in the EU as Wakix.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA