SUNOSI® (Solriamfetol) Pregnancy Registry

Conditions: Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring

Sex: Female

Healthy volunteers: No

Enrollment: 1731

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).

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06413420). StuddyBuddy aggregates publicly available trial information.