SUNOSI® (Solriamfetol) Pregnancy Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment.
- Who it may be relevant to
- Registry conditions: Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring
Overview
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
- 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
Primary outcome measures
- Long-term Safety [Time frame: Baseline up to 12 months after pregnancy outcome]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Evidera, a PPD business unit — Morrisville
- PPD, Inc. — Wilmington
Identifiers
NCT: NCT06413420 · JZP110-402