Excessive SleepinessPhase 3NCT06568367
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
A Phase 3 study testing Solriamfetol 150 mg and Solriamfetol 300 mg in people with Excessive Sleepiness and Shift-work Disorder, run by Axsome Therapeutics, Inc. at 49 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Excessive Sleepiness, Shift-work Disorder
- What is being tested?
- Solriamfetol 150 mg and Solriamfetol 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 49 sitesin 2 countries
- Study dates
- 1 Aug 2024to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
49 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
49 sites in 2 countries
United States44 sites, 41 recruiting
- Recruiting
Clinical Research Site
Anaheim, California, 92801
- Recruiting
Clinical Research Site
Atlanta, Georgia, 30238
- Recruiting
Clinical Research Site
Auburn, Alabama, 36832
- Recruiting
Clinical Research Site
Boston, Massachusetts, 02115
- Recruiting
Clinical Research Site
Brandon, Florida, 33511
- Recruiting
Clinical Research Site
Cerritos, California, 90703
- Recruiting
Clinical Research Site
Chandler, Arizona, 85224
- Recruiting
Clinical Research Site
Charleston, South Carolina, 29425
- Recruiting
Clinical Research Site
Chesterfield, Missouri, 63017
- Recruiting
Clinical Research Site
Chicago, Illinois, 60634
- Terminated
Clinical Research Site
Chula Vista, California, 91910
- Recruiting
Clinical Research Site
Cincinnati, Ohio, 45212
- Recruiting
Clinical Research Site
Cincinnati, Ohio, 45245
- Recruiting
Clinical Research Site
Colorado Springs, Colorado, 80918
- Recruiting
Clinical Research Site
Columbia, South Carolina, 29201
- Recruiting
Clinical Research Site
Cullman, Alabama, 35055
- Recruiting
Clinical Research Site
Denver, North Carolina, 28037
- Recruiting
Clinical Research Site
Fayetteville, North Carolina, 28304
- Recruiting
Clinical Research Site
Henderson, Nevada, 89052
- Recruiting
Clinical Research Site
Hialeah, Florida, 33016
- Recruiting
Clinical Research Site
Houston, Texas, 77058
- Recruiting
Clinical Research Site
Houston, Texas, 77070
- Recruiting
Clinical Research Site
Huntersville, North Carolina, 28078
- Recruiting
Clinical Research Site
Huntington Beach, California, 92647
- Recruiting
Clinical Research Site
Kenner, Louisiana, 70065
- Recruiting
Clinical Research Site
Lansing, Michigan, 48911
- Recruiting
Clinical Research Site
Little Rock, Arkansas, 72211
- Recruiting
Clinical Research Site
Long Beach, California, 90805
- Recruiting
Clinical Research Site
Miami, Florida, 33135
- Withdrawn
Clinical Research Site
Miami, Florida, 33144
- Recruiting
Clinical Research Site
Miami, Florida, 33176
- Recruiting
Clinical Research Site
Miami Lakes, Florida, 33016
- Recruiting
Clinical Research Site
Middletown, New Jersey, 07748
- Recruiting
Clinical Research Site
Novi, Michigan, 48377
- Recruiting
Clinical Research Site
San Antonio, Texas, 78229
- Recruiting
Clinical Research Site
Santa Ana, California, 92705
- Recruiting
Clinical Research Site
Southfield, Michigan, 48075
- Recruiting
Clinical Research Site
Spokane, Washington, 99204
- Recruiting
Clinical Research Site
St Louis, Missouri, 63123
- Recruiting
Clinical Research Site
Stockbridge, Georgia, 30281
- Recruiting
Clinical Research Site
Sugar Land, Texas, 77478
- Recruiting
Clinical Research Site
Towson, Maryland, 21286
- Withdrawn
Clinical Research Site
Tucson, Arizona, 85704
- Recruiting
Clinical Research Site
Wyomissing, Pennsylvania, 19610
Canada5 sites, 5 recruiting
- Recruiting
Clinical Research Site
Calgary, Alberta, T2Z 3A6
- Recruiting
Clinical Research Site
Markham, Ontario, L3R 1A3
- Recruiting
Clinical Research Site
Ottawa, Ontario, K2C 0P7
- Recruiting
Clinical Research Site
Toronto, Ontario, M4N 4M5
- Recruiting
Clinical Research Site
Toronto, Ontario, M5S 3A3
About this study
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
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).
Read the 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.
- Conditions
- Excessive Sleepiness, Shift-work Disorder
- Being tested
- Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo
- 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
- Medical subject headings
- Disorders of Excessive Somnolence, Sleep Initiation and Maintenance Disorders, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solriamfetol 150 mgDrug
Solriamfetol tablets, taken once daily
Solriamfetol 300 mgDrug
Solriamfetol tablets, taken once daily
PlaceboDrug
Placebo tablets, taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Solriamfetol 150mg | Experimental | Up to 12 weeks Receives: Drug: Solriamfetol 150 mg |
| Solriamfetol 300mg | Experimental | Up to 12 weeks Receives: Drug: Solriamfetol 300 mg |
| Placebo | Placebo comparator | Up to 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive SleepinessStudies of the same condition, open and under way.
- More trials run by Axsome Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568367
- Sponsor's protocol ID
- SOL-SWD-301
- Status last verified
- Jul 2026
- First submitted
- 21 Aug 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06568367
- Acronym / sponsor ID
- SOL-SWD-301
- Conditions
- Excessive Sleepiness, Shift-work Disorder
- Keywords
- Excessive Sleepiness, Solriamfetol, Sunosi, SWD, Dopamine norepinephrine reuptake inhibitor, Non-stimulant therapy, Insomnia, Circadian Rhythm Sleep Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Solriamfetol 150mg | Experimental | Drug: Solriamfetol 150 mgUp to 12 weeks |
| Solriamfetol 300mg | Experimental | Drug: Solriamfetol 300 mgUp to 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboUp to 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solriamfetol 150 mgSolriamfetol tablets, taken once daily | Drug | Solriamfetol 150mg |
| Solriamfetol 300 mgSolriamfetol tablets, taken once daily | Drug | Solriamfetol 300mg |
| PlaceboPlacebo tablets, taken once daily | Drug | Placebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- SUSTAIN Study WebsiteLink provided by the sponsor.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
49 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Solriamfetol 150 mg and Solriamfetol 300 mg in people with Excessive Sleepiness and Shift-work Disorder, run by Axsome Therapeutics, Inc. at 49 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (212-332-5061, sol-swd-301@axsome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.