Recruiting

Solriamfetol

Sponsor:

Axsome Therapeutics, Inc.

Code:

NCT06413420

Conditions

Narcolepsy

Obstructive Sleep Apnea

Pregnant Women and Their Offspring

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Sunosi (solriamfetol)

Other prescription wake-promoting medications or stimulants

No treatment

Study Details

Brief 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).

Conditions

Narcolepsy

Obstructive Sleep Apnea

Pregnant Women and Their Offspring

Study ID

NCT06413420

Start date

Jul 31, 2019

Status verified date

Sep, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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 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

Exclusion Criteria:

  • Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)

Study Design

Enrollment

1731 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA

Pregnant women with a diagnosis of narcolepsy or OSA

Cohort 2: Unexposed participants with narcolepsy or OSA

Pregnant women with a diagnosis of narcolepsy or OSA

Cohort 3: Other-exposed participants with narcolepsy or OSA

Pregnant women with a diagnosis of narcolepsy or OSA

Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA

Pregnant women without a diagnosis of narcolepsy or OSA

Cohort 5: Other-exposed participants without narcolepsy or OSA

Pregnant women without a diagnosis of narcolepsy or OSA

Interventions

Sunosi (solriamfetol)

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 stimulants

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

No treatment

Primary outcome measure

  • Long-term Safety [ Time Frame: Baseline up to 12 months after pregnancy outcome ]

Central Contacts and Locations

Central contacts

Study Director

1-877-283-6220sunosipregnancyregistry@ppd.com

Locations

Evidera, a PPD business unit

Recruiting

Morrisville, North Carolina, United States, 27560

PPD, Inc.

Recruiting

Wilmington, North Carolina, United States, 28401

More Information

Sponsor

Axsome Therapeutics, Inc.

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

  • Solriamfetol
  • SUNOSI
  • Axsome
  • Narcolepsy
  • Obstructive Sleep Apnea
  • Non-stimulant therapy
  • Dopamine norepinephrine reuptake inhibitor
  • Pregnancy outcomes
  • Infant outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Axsome Therapeutics, Inc. on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.