Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

November 20, 2025 updated by: Axsome Therapeutics, Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Markham, Ontario, Canada, L3R 1A3
        • Recruiting
        • Clinical Research Site
      • Toronto, Ontario, Canada, M5S 3A3
        • Recruiting
        • Clinical Research Site
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Recruiting
        • Clinical Research Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Clinical Research Site
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Clinical Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Clinical Research Site
    • California
      • Cerritos, California, United States, 90703
        • Recruiting
        • Clinical Research Site
      • Chula Vista, California, United States, 91910
        • Recruiting
        • Clinical Research Site
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • Clinical Research Site
      • Long Beach, California, United States, 90805
        • Recruiting
        • Clinical Research Site
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Clinical Research Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Recruiting
        • Clinical Research Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Clinical Research Site
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Clinical Research Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • Clinical Research Site
      • Miami, Florida, United States, 33135
        • Recruiting
        • Clinical Research Site
      • Miami, Florida, United States, 33144
        • Recruiting
        • Clinical Research Site
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Clinical Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30238
        • Recruiting
        • Clinical Research Site
      • Stockbridge, Georgia, United States, 30281
        • Recruiting
        • Clinical Research Site
    • Maryland
      • Towson, Maryland, United States, 21286
        • Recruiting
        • Clinical Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Clinical Research Site
    • Michigan
      • Lansing, Michigan, United States, 48911
        • Recruiting
        • Clinical Research Site
      • Novi, Michigan, United States, 48377
        • Recruiting
        • Clinical Research Site
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Clinical Research Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • Clinical Research Site
      • St Louis, Missouri, United States, 63123
        • Recruiting
        • Clinical Research Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Clinical Research Site
    • New Jersey
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Clinical Research Site
    • North Carolina
      • Denver, North Carolina, United States, 28037
        • Recruiting
        • Clinical Research Site
      • Fayetteville, North Carolina, United States, 28304
        • Recruiting
        • Clinical Research Site
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Clinical Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Recruiting
        • Clinical Research Site
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • Clinical Research Site
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Recruiting
        • Clinical Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Clinical Research Site
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • Clinical Research Site
    • Texas
      • Houston, Texas, United States, 77070
        • Recruiting
        • Clinical Research Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Clinical Research Site
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Up to 12 weeks
Drug: Placebo
Placebo tablets, taken once daily
Experimental: Solriamfetol 150mg
Up to 12 weeks
Drug: Solriamfetol 150 mg
Solriamfetol tablets, taken once daily
Experimental: Solriamfetol 300mg
Up to 12 weeks
Drug: Solriamfetol 300 mg
Solriamfetol tablets, taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOL-SWD-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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