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

Last updated: November 20, 2025
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Sleep Disorders

Narcolepsy

Treatment

Solriamfetol 150 mg

Placebo

Solriamfetol 300 mg

Clinical Study ID

NCT06568367
SOL-SWD-301
  • Ages 18-65
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 ofany study procedures.

  • Male or female, aged 18 to 65 inclusive.

Exclusion

Exclusion Criteria:

  • Prior exposure to solriamfetol/Sunosi, through either a clinical study orprescription.

  • Unable to comply with study procedures.

  • Medically inappropriate for study participation in the opinion of the investigator.

Study Design

Total Participants: 520
Treatment Group(s): 3
Primary Treatment: Solriamfetol 150 mg
Phase: 3
Study Start date:
August 01, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Clinical Research Site

    Markham 6066513, Ontario 6093943 L3R 1A3
    Canada

    Active - Recruiting

  • Clinical Research Site

    Toronto 6167865, Ontario 6093943 M5S 3A3
    Canada

    Active - Recruiting

  • Clinical Research Site

    Cullman 4057835, Alabama 4829764 35055
    United States

    Active - Recruiting

  • Clinical Research Site

    Chandler 5289282, Arizona 5551752 85224
    United States

    Active - Recruiting

  • Clinical Research Site

    Tucson 5318313, Arizona 5551752 85704
    United States

    Active - Recruiting

  • Clinical Research Site

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Clinical Research Site

    Little Rock 4119403, Arkansas 4099753 72211
    United States

    Active - Recruiting

  • Clinical Research Site

    Cerritos, California 90703
    United States

    Site Not Available

  • Clinical Research Site

    Chula Vista, California 91910
    United States

    Site Not Available

  • Clinical Research Site

    Long Beach, California 90805
    United States

    Site Not Available

  • Clinical Research Site

    Santa Ana, California 92705
    United States

    Site Not Available

  • Clinical Research Site

    Cerritos 5335663, California 5332921 90703
    United States

    Active - Recruiting

  • Clinical Research Site

    Chula Vista 5336899, California 5332921 91910
    United States

    Active - Recruiting

  • Clinical Research Site

    Huntington Beach 5358705, California 5332921 92647
    United States

    Active - Recruiting

  • Clinical Research Site

    Long Beach 5367929, California 5332921 90805
    United States

    Active - Recruiting

  • Clinical Research Site

    Santa Ana 5392900, California 5332921 92705
    United States

    Active - Recruiting

  • Clinical Research Site

    Colorado Springs, Colorado 80918
    United States

    Site Not Available

  • Clinical Research Site

    Colorado Springs 5417598, Colorado 5417618 80918
    United States

    Active - Recruiting

  • Clinical Research Site

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Clinical Research Site

    Miami, Florida 33144
    United States

    Site Not Available

  • Clinical Research Site

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Clinical Research Site

    Brandon 4148757, Florida 4155751 33511
    United States

    Active - Recruiting

  • Clinical Research Site

    Hialeah 4158476, Florida 4155751 33016
    United States

    Active - Recruiting

  • Clinical Research Site

    Miami 4164138, Florida 4155751 33176
    United States

    Active - Recruiting

  • Clinical Research Site

    Miami Lakes 4164186, Florida 4155751 33016
    United States

    Active - Recruiting

  • Clinical Research Site

    Atlanta, Georgia 30238
    United States

    Site Not Available

  • Clinical Research Site

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Clinical Research Site

    Atlanta 4180439, Georgia 4197000 30238
    United States

    Active - Recruiting

  • Clinical Research Site

    Stockbridge 4224681, Georgia 4197000 30281
    United States

    Active - Recruiting

  • Clinical Research Site

    Towson 4371582, Maryland 4361885 21286
    United States

    Active - Recruiting

  • Clinical Research Site

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • Clinical Research Site

    Lathrup Village, Michigan 48076
    United States

    Site Not Available

  • Clinical Research Site

    Novi, Michigan 48377
    United States

    Site Not Available

  • Clinical Research Site

    Lansing 4998830, Michigan 5001836 48911
    United States

    Active - Recruiting

  • Clinical Research Site

    Novi 5004062, Michigan 5001836 48377
    United States

    Active - Recruiting

  • Clinical Research Site

    Southfield 5010636, Michigan 5001836 48075
    United States

    Active - Recruiting

  • Clinical Research Site

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Clinical Research Site

    Saint Louis, Missouri 63123
    United States

    Site Not Available

  • Clinical Research Site

    Chesterfield 4381072, Missouri 4398678 63017
    United States

    Active - Recruiting

  • Clinical Research Site

    St Louis 4407066, Missouri 4398678 63123
    United States

    Active - Recruiting

  • Clinical Research Site

    Henderson 5505411, Nevada 5509151 89052
    United States

    Active - Recruiting

  • Clinical Research Site

    Middletown 5101170, New Jersey 5101760 07748
    United States

    Active - Recruiting

  • Clinical Research Site

    Denver, North Carolina 28037
    United States

    Site Not Available

  • Clinical Research Site

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Clinical Research Site

    Denver 4463523, North Carolina 4482348 28037
    United States

    Active - Recruiting

  • Clinical Research Site

    Fayetteville 4466033, North Carolina 4482348 28304
    United States

    Active - Recruiting

  • Clinical Research Site

    Huntersville 4472370, North Carolina 4482348 28078
    United States

    Active - Recruiting

  • Clinical Research Site

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Clinical Research Site

    Cincinnati 4508722, Ohio 5165418 45212
    United States

    Active - Recruiting

  • Clinical Research Site

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Clinical Research Site

    Wyomissing 5220248, Pennsylvania 6254927 19610
    United States

    Active - Recruiting

  • Clinical Research Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Clinical Research Site

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Clinical Research Site

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • Clinical Research Site

    Columbia 4575352, South Carolina 4597040 29201
    United States

    Active - Recruiting

  • Clinical Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Research Site

    Houston 4699066, Texas 4736286 77070
    United States

    Active - Recruiting

  • Clinical Research Site

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Clinical Research Site

    Sugar Land 4734825, Texas 4736286 77478
    United States

    Active - Recruiting

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