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SUNOSI® (Solriamfetol) Pregnancy Registry

Key facts

Where
Morrisville and Wilmington, United StatesSee the 2 sites

Where in United States

  • Evidera, a PPD business unitMorrisville, United StatesContact: Study DirectorTaking people
  • PPD, Inc.Wilmington, United StatesContact: Study DirectorTaking people

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

Trial details

Who runs it
Axsome Therapeutics, Inc.
Trial code
NCT06413420
Record updated
5 October 2026
Original description
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).Read full original descriptionShow less

SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring

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).

Inclusion: Pregnant women of any age; Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy or in the relevant exposure window before conception; Resident of the US or Canada; Provides written informed consent to participate in the study; Authorization for her HCP(s) to provide data to the registry.

Exclusion: Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC).

ClinicalTrials.gov NCT06413420