SUNOSI® (Solriamfetol) Pregnancy Registry

Launched by AXSOME THERAPEUTICS, INC. · May 9, 2024

Keywords

ClinConnect Summary

The SUNOSI® Pregnancy Registry is a study designed to understand how safe the medication solriamfetol is for pregnant women who have narcolepsy or obstructive sleep apnea, and for their babies. This study is open to pregnant women of any age who have been diagnosed with either of these sleep disorders or have taken solriamfetol or similar medications during their pregnancy. To participate, women need to live in a country where solriamfetol is available and must agree to let their healthcare providers share information with the study.

Participants in this study can expect to provide information about their health and pregnancy experiences, helping researchers learn more about the safety of solriamfetol during pregnancy. It’s important to note that women who have already had a pregnancy outcome before contacting the study center cannot participate. By joining this registry, women will contribute valuable information that could help improve the care of future pregnant women with narcolepsy or obstructive sleep apnea.

Gender

FEMALE

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
• • 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