Possible SUNOSI side effects

Here’s what you need to know about side effects

It’s important to understand the possible side effects of SUNOSI when talking to your doctor about treatments. The safety of SUNOSI was assessed during clinical studies in more than 900 people. People said that most of their side effects were mild to moderate.

The most common side effects were:

  • headache
  • decreased appetite
  • insomnia
  • nausea
  • anxiety
SUNOSI may cause serious side effects, including increased blood pressure and heart rate, and psychiatric symptoms like anxiety, problems sleeping, irritability, and agitation.
These are not all the possible side effects of SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop any side effects that do not go away during treatment with SUNOSI. Always take SUNOSI exactly as prescribed by your doctor.
You may report any side effects from prescription medications to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
3% of people stopped taking SUNOSI® due to side effects in the 12-week clinical studies, as compared with less than 1% with placebo.

OF PEOPLE STOPPED TAKING SUNOSI

due to side effects in the 12-week clinical studies, as compared to <1% with placebo

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INDICATION AND IMPORTANT SAFETY INFORMATION Expand ISI

Do not take SUNOSI if you are taking, or have stopped taking within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

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 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.
INDICATION AND IMPORTANT SAFETY INFORMATION
What is SUNOSI? SUNOSI (solriamfetol) is a prescription medicine used to improve wakefulness in adults with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA).
  • SUNOSI does not treat the underlying cause of OSA and SUNOSI does not take the place of any device prescribed for OSA, such as a continuous positive airway pressure (CPAP) machine. It is important that you continue to use these treatments as prescribed by your healthcare provider.
IMPORTANT SAFETY INFORMATION

Do not take SUNOSI if you are taking, or have stopped taking within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

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 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. 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, 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 any of these symptoms. 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.
SUNOSI (solriamfetol) is available in 75 mg and 150 mg tablets and is a federally controlled substance (CIV) 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.
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.

SUN CON ISI 06/2023

Please see Medication Guide.