NarcolepsyNCT06413420
SUNOSI® (Solriamfetol) Pregnancy Registry
An observational study of Narcolepsy and Obstructive Sleep Apnea, run by Axsome Therapeutics, Inc. at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
- What is being tested?
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants and No treatment
- How many people
- 1,731 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2019to Sep 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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 or in the relevant exposure window before conception
- Resident of the US or Canada
- Provides written informed consent to participate in the study
- Authorization for her HCP(s) to provide data to the registry
Who cannot join
- Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Evidera, a PPD business unit
Morrisville, North Carolina, 27560
- Recruiting
PPD, Inc.
Wilmington, North Carolina, 28401
About this study
Official title: SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring
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).
Read the 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.
- Being tested
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
- Keywords
- Solriamfetol, SUNOSI, Axsome, Narcolepsy, Obstructive Sleep Apnea, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Pregnancy outcomes, Infant outcomes
- Medical subject headings
- Narcolepsy, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunosi (solriamfetol)Drug
Exposure to at least 1 dose of solriamfetol at any time during pregnancy or in the relevant exposure window before conception.
Other prescription wake-promoting medications or stimulantsDrug
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 treatmentOther
No treatment
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA | Pregnant women with a diagnosis of narcolepsy or OSA Receives: Drug: Sunosi (solriamfetol) | |
| Cohort 2: Unexposed participants with narcolepsy or OSA | Pregnant women with a diagnosis of narcolepsy or OSA Receives: Other: No treatment | |
| Cohort 3: Other-exposed participants with narcolepsy or OSA | Pregnant women with a diagnosis of narcolepsy or OSA Receives: Drug: Other prescription wake-promoting medications or stimulants | |
| Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA | Pregnant women without a diagnosis of narcolepsy or OSA Receives: Drug: Sunosi (solriamfetol) | |
| Cohort 5: Other-exposed participants without narcolepsy or OSA | Pregnant women without a diagnosis of narcolepsy or OSA Receives: Drug: Other prescription wake-promoting medications or stimulants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Safety
Measured: Baseline up to 12 months after pregnancy outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start31 Jul 2019
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,731 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413420
- Sponsor's protocol ID
- JZP110-402
- Status last verified
- Sep 2026
- First submitted
- 9 May 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring
- ClinicalTrials.gov ID
- NCT06413420
- Acronym / sponsor ID
- JZP110-402
- Keywords
- Solriamfetol, SUNOSI, Axsome, Narcolepsy, Obstructive Sleep Apnea, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,731 participants (estimated)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA | – | Drug: Sunosi (solriamfetol)Pregnant women with a diagnosis of narcolepsy or OSA |
| Cohort 2: Unexposed participants with narcolepsy or OSA | – | Other: No treatmentPregnant women with a diagnosis of narcolepsy or OSA |
| Cohort 3: Other-exposed participants with narcolepsy or OSA | – | Drug: Other prescription wake-promoting medications or stimulantsPregnant women with a diagnosis of narcolepsy or OSA |
| Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA | – | Drug: Sunosi (solriamfetol)Pregnant women without a diagnosis of narcolepsy or OSA |
| Cohort 5: Other-exposed participants without narcolepsy or OSA | – | Drug: Other prescription wake-promoting medications or stimulantsPregnant women without a diagnosis of narcolepsy or OSA |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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 or in the relevant exposure window before conception
- Resident of the US or Canada
- Provides written informed consent to participate in the study
- Authorization for her HCP(s) to provide data to the registry
Key exclusion criteria (1 listed)
- Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunosi (solriamfetol)Exposure to at least 1 dose of solriamfetol at any time during pregnancy or in the relevant exposure window before conception. | Drug | Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA, Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA |
| Other prescription wake-promoting medications or stimulantsExposure 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. | Drug | Cohort 3: Other-exposed participants with narcolepsy or OSA, Cohort 5: Other-exposed participants without narcolepsy or OSA |
| No treatmentNo treatment | Other | Cohort 2: Unexposed participants with narcolepsy or OSA |
Primary outcome
Long-term Safety
Time frame: Baseline up to 12 months after pregnancy outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
- Sunosi Pregnancy Registry Recruitment WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy and Obstructive Sleep Apnea, run by Axsome Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (1-877-283-6220, sunosipregnancyregistry@ppd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term Safety (time frame: Baseline up to 12 months after pregnancy outcome). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.