Solriamfetol

Overview

Solriamfetol marketed under the brand name Sunosi by Jazz Pharmaceuticals in the United States is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated in treating daytime sleepiness associated with narcolepsy or obstructive sleep apnea. Solriamfetol was given FDA approval in 2019.

Indication

Solriamfetol is indicated for treatment of daytime sleepiness associated with obstructive sleep apnea and narcolepsy, but is not a treatment for the underlying airway obstruction in apnea patients.

Associated Conditions

Daytime Sleepiness

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.	2024/09/11	NCT06590662	Phase 2	Not yet recruiting	University Hospital, Montpellier
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)	2024/08/23	NCT06568367	Phase 3	Recruiting	Axsome Therapeutics, Inc.
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol	2024/05/14	NCT06413433	Phase 3	Recruiting	Axsome Therapeutics, Inc.
SUNOSI® (Solriamfetol) Pregnancy Registry	2024/05/14	NCT06413420	N/A	Recruiting	Axsome Therapeutics, Inc.
RECOVER-SLEEP: Platform Protocol	2024/05/08	NCT06404086	Phase 2	Recruiting	Duke University
RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)	2024/05/08	NCT06404099	Phase 2	Recruiting	Duke University
Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol	2024/04/11	NCT06360419	Phase 3	Completed	Axsome Therapeutics, Inc.
Solriamfetol for the Treatment of Multiple Sclerosis Fatigue	2023/12/14	NCT06170970	Phase 2	Recruiting	Johns Hopkins University
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA)	2023/10/27	NCT06103825	Phase 3	Completed	Ignis Therapeutics (Suzhou) Limited
A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)	2023/08/02	NCT05972044	Phase 3	Completed	Axsome Therapeutics, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
SUNOSI	Axsome Therapeutics, Inc.	81968-350	ORAL	75 mg in 1 1	3/24/2023
SUNOSI	Axsome Therapeutics, Inc.	81968-351	ORAL	150 mg in 1 1	3/24/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
SUNOSI TABLETS 75MG	N/A	Ignis Therapeutics (HK) Limited	N/A	N/A	10/11/2024
SUNOSI TABLETS 150MG	N/A	Ignis Therapeutics (HK) Limited	N/A	N/A	10/11/2024

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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