For excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea…. NDA 211230, held by Axsome Malta. Solriamfetol Hydrochloride.
As of Nov 14, 2026, NDA 211230 (Sunosi), held by Axsome Malta, was first approved by FDA on Mar 20, 2019, with 4 approved supplements and 0 published complete response letters.
SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities.
| Mar 20, 2019 | Original applicationEfficacy (new indication or use) · Standard review | Approved | |
| Mar 20, 2019 | Original applicationNew molecular entity · Standard review | Approved |
| SunosiEQ 75MG BASE · tablet;oral | Solriamfetol Hydrochloride | RxReference drug |
| SunosiEQ 150MG BASE · tablet;oral | Solriamfetol Hydrochloride | RxReference drug |
| Jun 28, 2023 | Supplement 9Labeling · Standard review | Approved | |
| Dec 1, 2022 | Supplement 7Labeling · Standard review | Approved | |
| Oct 20, 2021 | Supplement 4Labeling · Standard review | Approved | |
| Oct 7, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Mar 20, 2019 | Original applicationEfficacy (new indication or use) · Standard review | Approved | |
| Mar 20, 2019 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
