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SUNOSI® (Solriamfetol) Pregnancy Registry for Narcolepsy and Obstructive Sleep Apnea

This study is a registry to understand the safety of taking SUNOSI (solriamfetol) during pregnancy. SUNOSI is a medication used to treat excessive daytime sleepiness (EDS) caused by narcolepsy or obstructive sleep apnea (OSA). Researchers will collect health information from pregnant women who have taken SUNOSI or other wake-promoting medications, or no treatment, during pregnancy. The goal is to help patients and doctors make informed decisions about using SUNOSI during pregnancy. You can join if you are pregnant, have narcolepsy or OSA, or have taken solriamfetol or other wake-promoting medications during pregnancy, and live in a country where solriamfetol is available. The study will look at the long-term safety for you and your baby up to 12 months after your baby is born. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information from your medical records without giving you any specific treatment. It plans to enroll 1731 women.
What's involved
The study collects health information from you and your healthcare providers related to your pregnancy and developing baby. This data is collected up to 1 year after your baby is born.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for long-term safety up to 12 months after the pregnancy outcome.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06413420

SUNOSI® (Solriamfetol) Pregnancy Registry

Recruiting
Not specifiedAll AgesObservational
Axsome Therapeutics, Inc.
~1,731 participants
Updated 2024-05-14 on ClinicalTrials.gov
What's tested:Sunosi (solriamfetol)Other prescription wake-promoting medications or stimulantsNo treatment

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Long-term Safety
Measured over Baseline up to 12 months after pregnancy outcome

Conditions

Narcolepsy
Obstructive Sleep Apnea
Pregnant Women and Their Offspring

Explore related trials

NarcolepsyObstructive Sleep Apnea

Where it's being run

2 sites across 1 states
North Carolina2

Who to contact

Study Director
[email protected]
1-877-283-6220
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Long-term SafetyBaseline up to 12 months after pregnancy outcome