Sunosi
solriamfetol
Table of contents
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.
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List item
Sunosi : EPAR - Medicine overview (PDF/125.34 KB)
First published: 12/02/2020
EMA/40540/2020 -
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List item
Sunosi : EPAR - Risk-management-plan summary (PDF/178.9 KB)
First published: 12/02/2020
Authorisation details
Product details | |
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Name |
Sunosi
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Agency product number |
EMEA/H/C/004893
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Active substance |
solriamfetol hydrochloride
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International non-proprietary name (INN) or common name |
solriamfetol
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
N06BA14
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Additional 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 | |
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Marketing-authorisation holder |
TMC Pharma (EU) Limited
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Revision |
7
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Date of issue of marketing authorisation valid throughout the European Union |
16/01/2020
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Contact address |
7a Durands Cour |
Product information
13/12/2022 Sunosi - EMEA/H/C/004893 - IAIN/0018
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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).