This medicine is authorised for use in the European Union.


Wakix is used to treat narcolepsy in adults, adolescents and children from 6 years of age. Narcolepsy is a long-term sleep disorder which affects the brain’s ability to regulate the normal sleep-wake cycle. This leads to symptoms such as an irresistible urge to sleep, even at inappropriate times and places, and disturbed night-time sleep. Some patients also have episodes of severe muscle weakness (cataplexy) that can cause collapse. Wakix is used in patients with or without cataplexy.

Narcolepsy is rare, and Wakix was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 10 July 2007. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu307459.

Wakix contains the active substance pitolisant.

This EPAR was last updated on 20/04/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Bioprojet Pharma
Date of issue of marketing authorisation valid throughout the European Union
Contact address

9 rue Rameau
Paris 75002

Product information

24/02/2023 Wakix - EMEA/H/C/002616 - II/0030

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other nervous system drugs

Therapeutic indication

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).

Assessment history

Related content

How useful was this page?

Add your rating
1 rating
1 rating
1 rating
1 rating