A Phase 3 interventional study of Solriamfetol 150 mg and Solriamfetol 300 mg in Excessive Sleepiness and Shift-work Disorder, sponsored by Axsome Therapeutics, Inc.. Recruiting at 49 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Axsome Therapeutics, Inc. · Phase 3, Interventional, and Treatment
SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder (SWD).
Eligible subjects must meet the International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD). Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol titrated to either 150 mg, 300 mg, or placebo once per night shift for 12 weeks.
195 studies on the registry are indexed under Disorders of Excessive Somnolence; 33 are open to participants now.
This study's planned enrollment of 520 is above the median of 86 across 158 interventional studies indexed under Disorders of Excessive Somnolence.
Browse Disorders of Excessive Somnolence studies →Axsome Therapeutics, Inc. is the lead sponsor of 37 studies on the registry; 12 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 12 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Up to 12 weeks
Drug: Solriamfetol 150 mg
Up to 12 weeks
Drug: Solriamfetol 300 mg
Up to 12 weeks
Drug: Placebo
Solriamfetol tablets, taken once daily
Solriamfetol tablets, taken once daily
Placebo tablets, taken once daily
Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).
Time frame: 12 weeks
Change from Baseline to Week 12 in the Clinical Global Impressions of Severity of Illness (CGI-S) for sleepiness during the night shift.
Time frame: 12 weeks
Not enrolling at this site — choose another above.
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Plan to share: No
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Studies of the drug tested here: Solriamfetol
Disorders of Excessive Somnolence →