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Wakefulness-Promoting Agent

Solriamfetol for Shift Work Disorder

Phase 3
Recruiting
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 18 to 65 inclusive.
Be older than 18 years old
Must not have
Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

"This trial, called SUSTAIN, is testing the effectiveness and safety of solriamfetol in adults with excessive sleepiness due to shift work disorder. It is a Phase 3 trial

Who is the study for?
This trial is for adults with excessive sleepiness due to shift work disorder. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not detailed here.
What is being tested?
The SUSTAIN study tests the effects of Solriamfetol at two different doses (150 mg and 300 mg) compared to a placebo in managing sleepiness related to shift work. It's a Phase 3 trial where participants are randomly assigned to one of these groups without knowing which one they're in.
What are the potential side effects?
While specific side effects aren't listed, typical reactions may include headache, nausea, insomnia, anxiety or increased heart rate as Solriamfetol affects brain chemicals like dopamine and norepinephrine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have previously taken solriamfetol/Sunosi.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Solriamfetol 300mgExperimental Treatment1 Intervention
Up to 12 weeks
Group II: Solriamfetol 150mgExperimental Treatment1 Intervention
Up to 12 weeks
Group III: PlaceboPlacebo Group1 Intervention
Up to 12 weeks

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Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
31 Previous Clinical Trials
10,407 Total Patients Enrolled
~347 spots leftby Dec 2026
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