Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
Conditions
Keywords
Solriamfetol, SUNOSI, Axsome, Narcolepsy, Obstructive Sleep Apnea, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Pregnancy outcomes, Infant outcomes
Brief 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.
Interventions
DRUGSunosi (solriamfetol)
Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
DRUGOther 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.
OTHERNo treatment
No treatment
Sponsors
Axsome Therapeutics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term Safety | Baseline up to 12 months after pregnancy outcome |
Countries
United States
Contacts
Primary ContactStudy Director
Outcome results
None listed