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Evaluating Solriamfetol for Excessive Sleepiness in Shift Workers

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder

Phase 3 Interventional Axsome Therapeutics, Inc. · NCT06568367

This study is testing if a new medication called solriamfetol can help adults with excessive sleepiness from shift work feel more awake and alert.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment520 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorAxsome Therapeutics, Inc. Industry-sponsored
Locations40 sites (Cullman, Alabama and 39 other locations)
Trial IDNCT06568367 on ClinicalTrials.gov

What this trial studies

The SUSTAIN trial is a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of solriamfetol in adults experiencing excessive sleepiness due to shift work disorder (SWD). Participants will be randomly assigned to receive either solriamfetol at doses of 150 mg or 300 mg, or a placebo, administered once per night shift over a 12-week period. The study aims to determine how well solriamfetol modulates neurotransmitters associated with wakefulness and alertness in this population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 who meet the criteria for shift work disorder as defined by the International Classification of Sleep Disorders.

Not a fit: Patients who have previously been treated with solriamfetol or those deemed medically inappropriate for participation will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve alertness and quality of life for individuals suffering from excessive sleepiness related to shift work disorder.

How similar studies have performed: Previous studies have shown promise in using solriamfetol for sleep-related disorders, suggesting a potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Meets International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD)
* Provides written informed consent to participate in the study before the conduct of any study procedures.
* Male or female, aged 18 to 65 inclusive.

Exclusion Criteria:

* Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.

Where this trial is running

Cullman, Alabama and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Excessive SleepinessShift-work DisorderSolriamfetolSunosiSWDDopamine norepinephrine reuptake inhibitorNon-stimulant therapyInsomnia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.