An observational study in Narcolepsy, Obstructive Sleep Apnea and Pregnant Women and Their Offspring, sponsored by Axsome Therapeutics, Inc.. Recruiting at 2 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Axsome Therapeutics, Inc. · Observational
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).
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.
157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.
This study's planned enrollment of 1,731 is above the median of 135 across 38 observational studies indexed under Narcolepsy.
Browse Narcolepsy studies →Axsome Therapeutics, Inc. is the lead sponsor of 37 studies on the registry; 12 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 12 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 5, 2026. See what changed
The study population will include pregnant women of any age who reside in the US and Canada, provide consent to participate as well as medical releases for their healthcare providers (HCPs) to provide data to the registry, and meet the criteria for inclusion into 1 of the 5 cohorts.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women with a diagnosis of narcolepsy or OSA
Drug: Sunosi (solriamfetol)
Pregnant women with a diagnosis of narcolepsy or OSA
Other: No treatment
Pregnant women with a diagnosis of narcolepsy or OSA
Drug: Other prescription wake-promoting medications or stimulants
Pregnant women without a diagnosis of narcolepsy or OSA
Drug: Sunosi (solriamfetol)
Pregnant women without a diagnosis of narcolepsy or OSA
Drug: Other prescription wake-promoting medications or stimulants
Exposure to at least 1 dose of solriamfetol at any time during pregnancy or in the relevant exposure window before conception.
Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy or in the relevant exposure window before conception.
No treatment
Long-term Safety
Time frame: Baseline up to 12 months after pregnancy outcome
Plan to share: No
Started Jul 2019 (actual). Primary completion is estimated for Sep 2029, 122 months after the start.
Of 19 observational studies under Narcolepsy, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 73. This study's planned 122 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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