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

Last updated: July 23, 2026
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Narcolepsy

Sleep Disorders

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

    Calgary, Alberta T2Z 3A6
    Canada

    Active - Recruiting

  • Clinical Research Site

    Markham, Ontario L3R 1A3
    Canada

    Active - Recruiting

  • Clinical Research Site

    Ottawa, Ontario K2C 0P7
    Canada

    Active - Recruiting

  • Clinical Research Site

    Toronto, Ontario M5S 3A3
    Canada

    Active - Recruiting

  • Clinical Research Site

    Toronto, Ontario M4N 4M5
    Canada

    Active - Recruiting

  • Clinical Research Site

    Auburn, Alabama 36832
    United States

    Active - Recruiting

  • Clinical Research Site

    Cullman, Alabama 35055
    United States

    Active - Recruiting

  • Clinical Research Site

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Clinical Research Site

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Clinical Research Site

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Clinical Research Site

    Anaheim, California 92801
    United States

    Active - Recruiting

  • Clinical Research Site

    Cerritos, California 90703
    United States

    Active - Recruiting

  • Clinical Research Site

    Chula Vista, California 91910
    United States

    Terminated

  • Clinical Research Site

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Clinical Research Site

    Long Beach, California 90805
    United States

    Active - Recruiting

  • Clinical Research Site

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Clinical Research Site

    Colorado Springs, Colorado 80918
    United States

    Active - Recruiting

  • Clinical Research Site

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Clinical Research Site

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Clinical Research Site

    Miami, Florida 33144
    United States

    Site Not Available

  • Clinical Research Site

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Clinical Research Site

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Clinical Research Site

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Clinical Research Site

    Atlanta, Georgia 30238
    United States

    Active - Recruiting

  • Clinical Research Site

    Stockbridge, Georgia 30281
    United States

    Active - Recruiting

  • Clinical Research Site

    Chicago, Illinois 60634
    United States

    Active - Recruiting

  • Clinical Research Site

    Kenner, Louisiana 70065
    United States

    Active - Recruiting

  • Clinical Research Site

    Towson, Maryland 21286
    United States

    Active - Recruiting

  • Clinical Research Site

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Clinical Research Site

    Lansing, Michigan 48911
    United States

    Active - Recruiting

  • Clinical Research Site

    Novi, Michigan 48377
    United States

    Active - Recruiting

  • Clinical Research Site

    Southfield, Michigan 48075
    United States

    Active - Recruiting

  • Clinical Research Site

    Chesterfield, Missouri 63017
    United States

    Active - Recruiting

  • Clinical Research Site

    St Louis, Missouri 63123
    United States

    Active - Recruiting

  • Clinical Research Site

    Henderson, Nevada 89052
    United States

    Active - Recruiting

  • Clinical Research Site

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Clinical Research Site

    Denver, North Carolina 28037
    United States

    Active - Recruiting

  • Clinical Research Site

    Fayetteville, North Carolina 28304
    United States

    Active - Recruiting

  • Clinical Research Site

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Clinical Research Site

    Cincinnati, Ohio 45245
    United States

    Active - Recruiting

  • Clinical Research Site

    Cincinnati, Ohio 45212
    United States

    Active - Recruiting

  • Clinical Research Site

    Wyomissing, Pennsylvania 19610
    United States

    Active - Recruiting

  • Clinical Research Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Clinical Research Site

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

  • Clinical Research Site

    Houston, Texas 77058
    United States

    Active - Recruiting

  • Clinical Research Site

    Houston, Texas 77070
    United States

    Active - Recruiting

  • Clinical Research Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Clinical Research Site

    Sugar Land, Texas 77478
    United States

    Active - Recruiting

  • Clinical Research Site

    Spokane, Washington 99204
    United States

    Active - Recruiting

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