Sunosi

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solriamfetol

Authorised
This medicine is authorised for use in the European Union.

Overview

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 12/02/2020

Authorisation details

Product details
Name
Sunosi
Agency product number
EMEA/H/C/004893
Active substance
solriamfetol hydrochloride
International non-proprietary name (INN) or common name
solriamfetol
Therapeutic area (MeSH)
  • Narcolepsy
  • Sleep Apnea, Obstructive
Anatomical therapeutic chemical (ATC) code
N06BA14
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
Jazz Pharmaceuticals Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
16/01/2020
Contact address

Fifth Floor Waterloo Exchange
Waterloo Road
D04 E5W7
Dublin 4
Ireland

Product information

16/01/2020 Sunosi - EMEA/H/C/004893 -

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Pharmacotherapeutic group

Psychoanaleptics

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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