NCT06413420

SUNOSI® (Solriamfetol) Pregnancy Registry

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,731 (estimated)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The goal of the registry is to provide information on the safety of solriamfetol during pregnancy so that patients and physicians can weigh the benefits and risks of exposure during pregnancy and make informed treatment decisions. The study collects health information from enrolled pregnant women and their healthcare providers related to their pregnancies and developing babies up to 1 year of age. The registry is strictly observational. Only data that are routinely documented in patients' medical records during the course of usual care will be collected.

Conditions

• Narcolepsy
• Obstructive Sleep Apnea
• Pregnant Women and Their Offspring

Interventions

Type	Name	Description
DRUG	Sunosi (solriamfetol)	Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
DRUG	Other prescription wake-promoting medications or stimulants	Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.
OTHER	No treatment	No treatment

Timeline

• Start date: 2019-07-31
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2024-05-14
• Last updated: 2024-05-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study