This medicine is authorised for use in the European Union.


Sunosi is a medicine used to improve wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnoea.

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. Sunosi is used in patients with or without cataplexy (episodes of severe muscle weakness that can cause collapse). 

Obstructive sleep apnoea is repeated interruption of breathing during sleep due to airways becoming blocked. Sunosi is used when other treatments, such as continuous positive airway pressure (CPAP, use of a ventilator to keep the airways open), have not satisfactorily improved the excessive daytime sleepiness. 

Sunosi contains the active substance solriamfetol.

This EPAR was last updated on 14/12/2022

Authorisation details

Product details
Agency product number
Active substance
solriamfetol hydrochloride
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Narcolepsy
  • Sleep Apnea, Obstructive
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.

Publication details
Marketing-authorisation holder
TMC Pharma (EU) Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

7a Durands Cour
45 Parnell Street
Waterford X91 P381

Product information

13/12/2022 Sunosi - EMEA/H/C/004893 - IAIN/0018

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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


Therapeutic indication

Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy).

Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP). 

Assessment history

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