RESULTS WITH SUNOSI

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SUNOSI was studied across 4 clinical trials in people with excessive daytime sleepiness due to either obstructive sleep apnea (OSA) or narcolepsy.

In clinical trials, the 150 mg strength of SUNOSI improved wakefulness by:

88%
in people with obstructive sleep apnea

Compared to 2% improvement with placebo.

124%
in people with narcolepsy

Compared to 34% improvement with placebo.

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The majority of clinical trial participants said that SUNOSI improved their symptoms.

The Safety of Sunosi was evaluated in more than 900 people

In clinical trials, the most common side effects were headache, nausea, decreased appetite, anxiety, and problems sleeping. SUNOSI may cause serious side effects, including increased blood pressure and heart rate, and psychiatric symptoms like anxiety, problems sleeping, irritability, and agitation.

You should talk to your doctor to see if SUNOSI is right for you. Remember to report any side effects from prescription medications to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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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. 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 is SUNOSI?
SUNOSI 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 obstructive sleep apnea and does not take the place of any device prescribed for obstructive sleep apnea, 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
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.

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.
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.