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SUNOSI® (Solriamfetol) Pregnancy Registry
Sponsor: Axsome Therapeutics, Inc.
Summary
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).
Official title: SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
1731
Start Date
2019-07-31
Completion Date
2029-09
Last Updated
2026-10-05
Healthy Volunteers
No
Interventions
Sunosi (solriamfetol)
Exposure to at least 1 dose of solriamfetol at any time during pregnancy or in the relevant exposure window before conception.
Other prescription wake-promoting medications or stimulants
Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy or in the relevant exposure window before conception.
No treatment
No treatment
Locations (2)
Evidera, a PPD business unit
Morrisville, North Carolina, United States
PPD, Inc.
Wilmington, North Carolina, United States