Source: FDA, National Drug Code (US) Revision Year: 2020
SUNOSI contains solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI). Solriamfetol is a phenylalanine derivative with the systematic name (R)‑2-amino‑3‑phenylpropylcarbamate hydrochloride.
The molecular formula is C10H15N2O2Cl, and the molecular weight is 230.69.
The chemical structure is:
Solriamfetol hydrochloride is a white to off-white solid that is freely soluble in water.
SUNOSI tablets are intended for oral administration. Each 75 mg SUNOSI film‑coated tablet contains 75 mg solriamfetol (equivalent to 89.3 mg solriamfetol hydrochloride). Each 150 mg SUNOSI film‑coated tablet contains 150 mg solriamfetol (equivalent to 178.5 mg solriamfetol hydrochloride). The inactive ingredients are hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
| Dosage Forms and Strengths |
|---|
|
SUNOSI 75 mg – (75 mg solriamfetol equivalent to 89.3 mg of the hydrochloride salt) dark yellow oblong tablet with “75” debossed on one side and a functional score line on the opposite side. SUNOSI 150 mg – (150 mg solriamfetol equivalent to 178.5 mg of the hydrochloride salt) yellow oblong tablet with “150” debossed on one side. |
| How Supplied |
|---|
|
SUNOSI is packaged in 30‑count and 100‑count white, high density polyethylene (HDPE) bottles. SUNOSI tablets, 75 mg ‑ dark yellow oblong tablet with “75” debossed on one side and a functional score line on the opposite side. SUNOSI tablets, 150 mg ‑ yellow oblong tablet with “150” debossed on one side. |
| Drug | Countries | |
|---|---|---|
| SUNOSI | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, United Kingdom, United States |
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