Home › Narcolepsy › NCT06413420

SUNOSI® (Solriamfetol) Pregnancy Registry

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

Who can join

All ages · Women

Inclusion Criteria:

* 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
* Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA
* Provides written informed consent to participate in the study
* Authorization for her HCP(s) to provide data to the registry

Exclusion Criteria:

* Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
* Inclusion of a prior pregnancy in the main analysis population

About the study

The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).

What is being tested

• Sunosi (solriamfetol) (drug)
• Other prescription wake-promoting medications or stimulants (drug)
• No treatment (other)

Sponsor: Axsome Therapeutics, Inc. · Participants: 1,731 · Started: Jul 31, 2019

Contact the study team

• Study Director · Phone: 1-877-283-6220

Official record on ClinicalTrials.gov — NCT06413420

Locations in the U.S.

Conditions

• Narcolepsy
• Obstructive Sleep Apnea

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.