Wakix

pitolisant · Bioprojet Pharma
ORPHAN AUTHORISED IN THE EU

What Wakix is used 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).

Approved use, as published by the European Medicines Agency.

What the labels mean

  • Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).

Key facts

Brand
Wakix
Active substance
pitolisant
Disease area
Narcolepsy
Medicine group
Other nervous system drugs
ATC code
N07XX11
Marketing authorisation holder
Bioprojet Pharma
Authorised in the EU since
2016

Official information

In the USA

Same active substance: Wakix

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 used 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).

What is the active substance in Wakix?

Wakix contains pitolisant.

Who makes Wakix?

The EU marketing authorisation holder is Bioprojet Pharma.

Is Wakix an orphan medicine?

Yes. Wakix is designated an orphan medicine in the EU, for a rare disease (Narcolepsy).

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

← All specialty medicines, EU

For information only, not medical advice. This page is a plain-language summary written from standard prescribing information and the public guides linked below. Brands sometimes change their formula, so always check the composition printed on the pack. Doses here are typical adult doses; yours may differ. Do not start, stop or change a medicine without your doctor or pharmacist, and keep all medicines away from children. In an emergency, call 112 (India) or your local emergency number.