SUNOSI® (Solriamfetol) Pregnancy Registry
← catalyst calendarNCT06413420 · readout ≤ 1,138 d
Sponsored by Axsome Therapeutics, Inc. (industry) · AXSM — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
1,731estimated
Sites
2
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-07-31 | actual | When the study began enrolling |
| Primary completion | Sep 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2024-05-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2024-05-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Narcolepsy
- Obstructive Sleep Apnea
- Pregnant Women and Their Offspring
Interventions
- Drug: Sunosi (solriamfetol)
- Drug: Other prescription wake-promoting medications or stimulants
- Other: No treatment
Primary outcome
what the primary-completion date above is the date OFLong-term Safety
measured Baseline up to 12 months after pregnancy outcome
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