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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06568367

Enrollment

520

Registered

2024-08-23

Start date

2024-08-01

Completion date

2026-12-01

Last updated

2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Excessive Sleepiness, Shift-work Disorder

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

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).

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.

Interventions

DRUGSolriamfetol 150 mg

Solriamfetol tablets, taken once daily

DRUGSolriamfetol 300 mg

Solriamfetol tablets, taken once daily

DRUGPlacebo

Placebo tablets, taken once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).	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.	12 weeks

Countries

Canada, United States

Contacts

CONTACTStudy Director

sol-swd-301@axsome.com212-332-5061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026