Why enroll in the SUNOSI Pregnancy Registry?

We encourage you to voluntarily enroll in the SUNOSI Pregnancy Registry and help us learn more about the health of infants born to mothers taking SUNOSI during pregnancy. Your participation may help other women and their babies in the future.

What is required for me to be eligible to participate?

  • You must be a U.S. resident
  • You must currently be pregnant, or have already delivered, and your infant has been diagnosed with a birth defect
  • You must have taken at least one dose of SUNOSI during pregnancy. We will confirm your SUNOSI use with your healthcare provider after you provide consent.

Will I be compensated for participating in the Registry?

  • You will receive $50.00 for your participation in the Registry.
  • Earn $25 after the registry confirms with your healthcare provider that you are eligible
  • Receive another $25 when your infant reaches 1 year and/or when your infant’s healthcare provider confirms they have no further information available

Is it easy to enroll in the Registry?

Yes, simply contact a Registry staff member via phone or email to enroll.

You can also download the Participant Consent to Contact Card, fill it out and send it to us via email or fax.

  • Fax number: Toll-free 1-877-284-3341

Call the SUNOSI Pregnancy Registry toll-free at 1-877-283-6220 or email: SunosiPregnancyRegistry@ppdi.com


Limitations of Use: SUNOSI is not for use to treat the underlying cause of airway obstruction in people with OSA. SUNOSI does not take the place of using your continuous positive airway pressure (CPAP) machine or other devices that your healthcare provider has prescribed for the treatment of OSA. It is important that you continue to use these treatments as prescribed by your healthcare provider.

IMPORTANT SAFETY INFORMATION

SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure, and death. Your doctor should check your blood pressure before you start and during treatment with SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI.
SUNOSI (solriamfetol) 75 mg and 150 mg tablets is a federally controlled substance (C-IV) because it contains solriamfetol that can be a target for people who abuse prescription medicines or street drugs. Keep SUNOSI in a safe place to protect it from theft. Never give or sell your SUNOSI to anyone else because it may cause death or harm them and it is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Before taking SUNOSI, tell your doctor about all of your medical conditions, including if you:
  • have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol
  • have had a heart attack or a stroke
  • have kidney problems or diabetes
  • have a history of mental health problems (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction
  • are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SUNOSI passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUNOSI.
What are the possible side effects of SUNOSI?
SUNOSI may cause serious side effects, including:
  • Increased blood pressure and heart rate. SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure, and death. Your doctor should check your blood pressure before you start and during treatment with SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI.
  • Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability, and agitation. Tell your doctor if you develop anxiety, problems sleeping, irritability, agitation. Your doctor may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI.
The most common side effects of SUNOSI include:
  • headache
  • nausea
  • decreased appetite
  • anxiety
  • problems sleeping
These are not all the possible side effects of SUNOSI. Call your doctor for advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information and Medication Guide.
Open ISI

IMPORTANT SAFETY INFORMATION

SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure, and death. Your doctor should check your blood pressure before you start and during treatment with SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI.
SUNOSI (solriamfetol) 75 mg and 150 mg tablets is a federally controlled substance (C-IV) because it contains solriamfetol that can be a target for people who abuse prescription medicines or street drugs. Keep SUNOSI in a safe place to protect it from theft. Never give or sell your SUNOSI to anyone else because it may cause death or harm them and it is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Before taking SUNOSI, tell your doctor about all of your medical conditions, including if you:
  • have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol
  • have had a heart attack or a stroke
  • have kidney problems or diabetes
  • have a history of mental health problems (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction
  • are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SUNOSI passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUNOSI.
What are the possible side effects of SUNOSI?
SUNOSI may cause serious side effects, including:
  • Increased blood pressure and heart rate. SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure, and death. Your doctor should check your blood pressure before you start and during treatment with SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI.
  • Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability, and agitation. Tell your doctor if you develop anxiety, problems sleeping, irritability, agitation. Your doctor may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI.
The most common side effects of SUNOSI include:
  • headache
  • nausea
  • decreased appetite
  • anxiety
  • problems sleeping
These are not all the possible side effects of SUNOSI. Call your doctor for advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information and Medication Guide.