Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Atnahs Pharma Netherlands B. V., Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Denmark
Sunosi 75 mg film-coated tablets.
Sunosi 150 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Sunosi 75 mg film-coated tablets: Yellow to dark yellow oblong tablet, 7.6 mm x 4.4 mm, with “75” debossed on one side and a score line on the opposite side. The tablet can be divided into equal doses. Sunosi 150 mg film-coated tablets: Yellow oblong tablet, 9.5 mm x 5.6 mm, with “150” debossed on one side. |
Sunosi 75 mg film-coated tablets: Each tablet contains solriamfetol hydrochloride equivalent to 75 mg of solriamfetol.
Sunosi 150 mg film-coated tablets: Each tablet contains solriamfetol hydrochloride, equivalent to 150 mg of solriamfetol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Solriamfetol |
The mechanism(s) of solriamfetol to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea has not been fully characterised. However, its efficacy could be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor (DNRI). |
| List of Excipients |
|---|
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Tablet core: Hydroxypropyl cellulose Film coating: Poly(vinyl alcohol) |
7 × 1 film coated tablets in PVC/PCTFE/Aluminium perforated unit dose blisters.
PVC/PCTFE/Aluminium blister.
Packs containing 7, 28 or 56 film-coated tablets.
High density polyethylene (HDPE) bottle with polypropylene (PP) child-resistant cap with integrated silica gel desiccant. Each bottle contains 30 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Atnahs Pharma Netherlands B. V., Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Denmark
EU/1/19/1408/001
EU/1/19/1408/002
EU/1/19/1408/003
EU/1/19/1408/004
EU/1/19/1408/005
EU/1/19/1408/006
EU/1/19/1408/007
EU/1/19/1408/008
EU/1/19/1408/009
EU/1/19/1408/010
Date of first authorisation: 16 January 2020
| Drug | Countries | |
|---|---|---|
| SUNOSI | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, United Kingdom, United States |
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