About SUNOSI

SUNOSI is a once-daily medication and is a wake-promoting agent. It works differently than other excessive daytime sleepiness (EDS) medications and can help increase your wakefulness if you have EDS due to obstructive sleep apnea (OSA) or narcolepsy.

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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).

SUNOSI is not a stimulant. It’s a wake-promoting agent and is made of a medication called solriamfetol.

SUNOSI works quickly—you can experience more wakefulness in as little as 1 hour. People saw this result at week 12 in clinical studies.*

It is not known if SUNOSI is safe and effective in children.

SUNOSI was not shown to cause symptoms of withdrawal or dependence in clinical studies following sudden stoppage of the drug.

SUNOSI is a controlled substance because it has potential for, and can be a target of, abuse. Keep SUNOSI in a safe place to protect it from theft. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

SUNOSI does not treat the cause of obstructive sleep apnea or take the place of your CPAP. It is important that you continue to use these treatments as prescribed by your doctor.

*The 75 mg dose did not show improvement in patients with narcolepsy.

How SUNOSI works differently

SUNOSI is thought to work on 2 natural chemicals in the brain—dopamine and norepinephrine—to help keep you awake during the day. SUNOSI improves wakefulness by increasing their activity.

SUNOSI is the first and only approved medication for EDS due to OSA or narcolepsy that works this way.

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.