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Taking people in United StatesPhase 3

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

Key facts

Who runs it
Axsome Therapeutics, Inc.
Where
Anaheim, Atlanta, Auburn, Boston, Brandon, Cerritos, Chandler, Charleston, Chesterfield, Chicago, Chula Vista, Cincinnati, Colorado Springs, Columbia, Cullman, Denver, Fayetteville, Henderson, Hialeah, Houston, Huntersville, Huntington Beach, Kenner, Lansing, Little Rock, Long Beach, Miami, Miami Lakes, Middletown, Novi, San Antonio, Santa Ana, Southfield, Spokane, St Louis, Stockbridge, Sugar Land, Towson, Tucson, and Wyomissing, United StatesSee the 40 sitesAlso in 1 other country, 4 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
520 people, planned
Started
1 Aug 2024
Expected to end
Dec 2026
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Solriamfetol 150 mg
  • Solriamfetol 300 mg
  • Placebo
Record updated
24 July 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in United States

Also in 1 other country, 4 sites

  • Anaheim, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Atlanta, GeorgiaHospital not named in the registryContact: Study DirectorTaking people
  • Auburn, AlabamaHospital not named in the registryContact: Study DirectorTaking people
  • Boston, MassachusettsHospital not named in the registryContact: Study DirectorTaking people
  • Brandon, FloridaHospital not named in the registryContact: Study DirectorTaking people
  • Cerritos, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Chandler, ArizonaHospital not named in the registryContact: Study DirectorTaking people
  • Charleston, South CarolinaHospital not named in the registryContact: Study DirectorTaking people
  • Chesterfield, MissouriHospital not named in the registryContact: Study DirectorTaking people
  • Chicago, IllinoisHospital not named in the registryContact: Study DirectorTaking people
  • Chula Vista, CaliforniaHospital not named in the registryContact: Study DirectorNo longer taking part
  • Cincinnati, OhioHospital not named in the registryContact: Study DirectorTaking people
  • Colorado Springs, ColoradoHospital not named in the registryContact: Study DirectorTaking people
  • Columbia, South CarolinaHospital not named in the registryContact: Study DirectorTaking people
  • Cullman, AlabamaHospital not named in the registryContact: Study DirectorTaking people
  • Denver, North CarolinaHospital not named in the registryContact: Study DirectorTaking people
  • Fayetteville, North CarolinaHospital not named in the registryContact: Study DirectorTaking people
  • Henderson, NevadaHospital not named in the registryContact: Study DirectorTaking people
  • Hialeah, FloridaHospital not named in the registryContact: Study DirectorTaking people
  • Houston, TexasHospital not named in the registryContact: Study DirectorTaking people
  • Huntersville, North CarolinaHospital not named in the registryContact: Study DirectorTaking people
  • Huntington Beach, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Kenner, LouisianaHospital not named in the registryContact: Study DirectorTaking people
  • Lansing, MichiganHospital not named in the registryContact: Study DirectorTaking people
  • Little Rock, ArkansasHospital not named in the registryContact: Study DirectorTaking people
  • Long Beach, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Miami, FloridaHospital not named in the registryContact: Study DirectorTaking people
  • Miami Lakes, FloridaHospital not named in the registryContact: Study DirectorTaking people
  • Middletown, New JerseyHospital not named in the registryContact: Study DirectorTaking people
  • Novi, MichiganHospital not named in the registryContact: Study DirectorTaking people
  • San Antonio, TexasHospital not named in the registryContact: Study DirectorTaking people
  • Santa Ana, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Southfield, MichiganHospital not named in the registryContact: Study DirectorTaking people
  • Spokane, WashingtonHospital not named in the registryContact: Study DirectorTaking people
  • St Louis, MissouriHospital not named in the registryContact: Study DirectorTaking people
  • Stockbridge, GeorgiaHospital not named in the registryContact: Study DirectorTaking people
  • Sugar Land, TexasHospital not named in the registryContact: Study DirectorTaking people
  • Towson, MarylandHospital not named in the registryContact: Study DirectorTaking people
  • Tucson, ArizonaHospital not named in the registryContact: Study DirectorNo longer taking part
  • Wyomissing, PennsylvaniaHospital not named in the registryContact: Study DirectorTaking people

About the trial

What the trial wants to find out

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).

The 3 groups in the trial

  • Solriamfetol 150mgTreatment being tested

    Up to 12 weeks

    Treatment: Solriamfetol 150 mg

  • Solriamfetol 300mgTreatment being tested

    Up to 12 weeks

    Treatment: Solriamfetol 300 mg

  • PlaceboPlacebo, for comparison

    Up to 12 weeks

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Fit questions
Built from NCT06568367, who can take part
Record updated
24 July 2026