SUNOSI Solriamfetol Pregnancy Registry Observational Study on Safety During Pregnancy in Women with Narcolepsy or Obstructive Sleep Apnea

What This Trial Is About

Researchers are collecting information in the SUNOSI solriamfetol Pregnancy Registry to understand the safety of solriamfetol exposure during pregnancy among women diagnosed with narcolepsy or obstructive sleep apnea OSA. This observational study is based in the US and Canada and aims to help patients and doctors make informed decisions about using solriamfetol during pregnancy. The study observes pregnant women in several groups those exposed to solriamfetol or other prescription wake-promoting medications or stimulants during pregnancy or before conception, with or without narcolepsy or OSA, as well as those not exposed to these treatments. No treatments or interventions are given as part of the study it only collects health data routinely recorded during usual care. Participants provide health information about their pregnancies and their babies, with data collected up to 12 months after the pregnancy outcome. The study measures long-term safety outcomes from baseline through one year after delivery. This information is gathered through medical records and reports from healthcare providers without additional procedures or treatments required for the registry.

SUNOSI® (Solriamfetol) Pregnancy Registry