Recruiting
Phase 3

Solriamfetol

Sponsor:

Axsome Therapeutics, Inc.

Code:

NCT06568367

Conditions

Excessive Sleepiness

Shift-work Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Solriamfetol 150 mg

Solriamfetol 300 mg

Placebo

Study Details

Brief 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).

Conditions

Excessive Sleepiness

Shift-work Disorder

Study ID

NCT06568367

Start date

Aug 1, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

520 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Solriamfetol 150mg

Up to 12 weeks

experimental: Solriamfetol 300mg

Up to 12 weeks

placebo comparator: Placebo

Up to 12 weeks

Interventions

Solriamfetol 150 mg

Solriamfetol tablets, taken once daily

Solriamfetol 300 mg

Solriamfetol tablets, taken once daily

Placebo

Placebo tablets, taken once daily

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Study Director

212-332-5061sol-swd-301@axsome.com

Locations

Clinical Research Site

Recruiting

Auburn, Alabama, United States, 36832

Clinical Research Site

Recruiting

Cullman, Alabama, United States, 35055

Clinical Research Site

Recruiting

Chandler, Arizona, United States, 85224

Clinical Research Site

Recruiting

Little Rock, Arkansas, United States, 72211

Clinical Research Site

Recruiting

Anaheim, California, United States, 92801

Clinical Research Site

Recruiting

Cerritos, California, United States, 90703

Clinical Research Site

Recruiting

Huntington Beach, California, United States, 92647

Clinical Research Site

Recruiting

Long Beach, California, United States, 90805

Clinical Research Site

Recruiting

Santa Ana, California, United States, 92705

Clinical Research Site

Recruiting

Colorado Springs, Colorado, United States, 80918

Clinical Research Site

Recruiting

Brandon, Florida, United States, 33511

Clinical Research Site

Recruiting

Hialeah, Florida, United States, 33016

Clinical Research Site

Recruiting

Miami, Florida, United States, 33135

Clinical Research Site

Recruiting

Miami, Florida, United States, 33176

Clinical Research Site

Recruiting

Miami Lakes, Florida, United States, 33016

Clinical Research Site

Recruiting

Atlanta, Georgia, United States, 30238

Clinical Research Site

Recruiting

Stockbridge, Georgia, United States, 30281

Clinical Research Site

Recruiting

Chicago, Illinois, United States, 60634

Clinical Research Site

Recruiting

Kenner, Louisiana, United States, 70065

Clinical Research Site

Recruiting

Towson, Maryland, United States, 21286

Clinical Research Site

Recruiting

Boston, Massachusetts, United States, 02115

Clinical Research Site

Recruiting

Lansing, Michigan, United States, 48911

Clinical Research Site

Recruiting

Novi, Michigan, United States, 48377

Clinical Research Site

Recruiting

Southfield, Michigan, United States, 48075

Clinical Research Site

Recruiting

Chesterfield, Missouri, United States, 63017

Clinical Research Site

Recruiting

St Louis, Missouri, United States, 63123

Clinical Research Site

Recruiting

Henderson, Nevada, United States, 89052

Clinical Research Site

Recruiting

Middletown, New Jersey, United States, 07748

Clinical Research Site

Recruiting

Denver, North Carolina, United States, 28037

Clinical Research Site

Recruiting

Fayetteville, North Carolina, United States, 28304

Clinical Research Site

Recruiting

Huntersville, North Carolina, United States, 28078

Clinical Research Site

Recruiting

Cincinnati, Ohio, United States, 45212

Clinical Research Site

Recruiting

Cincinnati, Ohio, United States, 45245

Clinical Research Site

Recruiting

Wyomissing, Pennsylvania, United States, 19610

Clinical Research Site

Recruiting

Charleston, South Carolina, United States, 29425

Clinical Research Site

Recruiting

Columbia, South Carolina, United States, 29201

Clinical Research Site

Recruiting

Houston, Texas, United States, 77058

Clinical Research Site

Recruiting

Houston, Texas, United States, 77070

Clinical Research Site

Recruiting

San Antonio, Texas, United States, 78229

Clinical Research Site

Recruiting

Sugar Land, Texas, United States, 77478

Clinical Research Site

Recruiting

Spokane, Washington, United States, 99204

Clinical Research Site

Recruiting

Calgary, Alberta, Canada, T2Z 3A6

Clinical Research Site

Recruiting

Markham, Ontario, Canada, L3R 1A3

Clinical Research Site

Recruiting

Ottawa, Ontario, Canada, K2C 0P7

Clinical Research Site

Recruiting

Toronto, Ontario, Canada, M4N 4M5

Clinical Research Site

Recruiting

Toronto, Ontario, Canada, M5S 3A3

More Information

Sponsor

Axsome Therapeutics, Inc.

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Excessive Sleepiness
  • Solriamfetol
  • Sunosi
  • SWD
  • Dopamine norepinephrine reuptake inhibitor
  • Non-stimulant therapy
  • Insomnia
  • Circadian Rhythm Sleep Disorder
  • Trace amine-associated receptor 1 (TAAR1) agonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Axsome Therapeutics, Inc. on 2026-07-24.