The SUNOSI Pregnancy Registry

Are you a healthcare provider who treats pregnant women with narcolepsy or obstructive sleep apnea (OSA)?

ORAre you a healthcare provider who prescribes wake-promoting medications and stimulants to patients with excessive daytime sleepiness?

Help us learn more about the safety of using SUNOSI® (solriamfetol) and other wake-promoting medications and stimulants during pregnancy.

Who is eligible to participate?

Patients may be eligible if they are:
  • Taking or have taken SUNOSI® (solriamfetol) for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA during pregnancy
OR
  • A pregnant woman diagnosed with narcolepsy or OSA
OR
  • A pregnant woman who does not have a diagnosis of narcolepsy or OSA, but who has taken at least one dose of SUNOSI or another wake-promoting medication or stimulant during pregnancy (since the first day of her last menstrual period)

*Participants will be considered exposed during pregnancy if a dose is taken during the short period of time just prior to conception, between the first day of the last menstrual period and the date of conception.

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How do I enroll a patient?

If you have patients who you think may be eligible, you can help them enroll by having them:

Complete the Potential Participant Contact Request Form here and a Registry team member will contact them.

Call the registry team toll-free at
1-877-283-6220
(hours of operation 8.30 am – 5.00 pm ET Monday-Friday)

Download the study database or app by clicking here. When prompted for a registration code, enter USA-1779-0027 (US resident) or CAN-1779-4042 (Canada resident). This option is only available to adults. If you are a minor, please contact the registry directly.

Why is this study needed?

Since pregnant women are excluded from clinical trial participation, there is limited data on the potential impact of exposure to wake-promoting medications and stimulants on pregnancy and infant outcomes.

What does participation involve?

Eligible patients and their healthcare providers will provide information to the registry about their pregnancies and the health of their infants up to 1 year of age. This information can be provided by completing paper forms, via the free registry app or website portal, or via short phone interviews with one of the registry staff members. Only information normally documented in patients’ medical records will be collected.

There will be:

  • No extra doctor’s visits or additional testing
  • No changes to patients’ medications or care

Eligible patients and their healthcare provider(s) will receive compensation for providing data to the registry.

What information is collected?

Eligible patients will be asked to provide basic demographic information (e.g., race, ethnicity, education, height and weight) at enrollment.

The pregnant woman’s healthcare provider(s) will asked to provide data at enrollment, approximately the end of the 2nd trimester, and pregnancy outcome. For live-born infants, healthcare provider(s) will be asked to provide data at approximately 4 and 12 months after delivery.

The following data will be collected:

  • Maternal obstetrical history
  • Family history of congenital malformations
  • Narcolepsy or OSA history, if applicable
  • Baseline and ongoing pregnancy information, including pregnancy dating and prenatal test information
  • Maternal exposures during pregnancy
  • Maternal medical conditions and pregnancy complications
  • Pregnancy outcome information, including fetus/infant characteristics and presence of congenital malformations
  • Infant growth and development information

Healthcare providers will receive $50 each time-point they submit data to the registry.

Thank you for your support in recruiting potential participants.