US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| SUNOSI | EQ 75MG BASE; EQ 150MG BASE | tablet · oral | AXSOME MALTA | Prescription | 20 Mar 2019 |
| SOLRIAMFETOL HYDROCHLORIDE | EQ 75MG BASE; EQ 150MG BASE | tablet · oral | HIKMA PHARMS | Prescription | 17 Jun 2026 |
| SOLRIAMFETOL HYDROCHLORIDE | EQ 75MG BASE; EQ 150MG BASE | tablet · oral | ALKEM LABS LTD | Prescription | 17 Jun 2026 |
EMA European Union — centrally authorised medicines
Sunosi Atnahs Pharma Netherlands B.V. · Authorised · authorised 16 Jan 2020 · ATC N06BA14
Therapeutic indication (EMA)
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).
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| SUNOSI | 02515814 | 75 MG | TABLET · ORAL | AXSOME MALTA LTD. |
| SUNOSI | 02515822 | 150 MG | TABLET · ORAL | AXSOME MALTA LTD. |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | SUNOSI 150 MG TABLET | $31.34292 | per EA | 23 Sep 2026 |
| US NADAC | SUNOSI 75 MG TABLET | $31.36909 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.