Sunosi is a prescription medicine used to treat excessive daytime sleepiness in adults with narcolepsy or in those whose sleep is disrupted by sleep apnea.

Sunosi will not treat sleep apnea. Keep using your CPAP machine or other device prescribed by your doctor.

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

Do not use Sunosi if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Sunosi is a federally controlled substance as it contains solriamfetol. This medicine 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 your Sunosi to anyone else, because it may cause death or harm them. Selling or giving away this medicine may harm others and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Take Sunosi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Sunosi is usually taken once daily when you wake up.

You may take Sunosi with or without food.

You may need to swallow a tablet whole or split it in half. Follow your doctor's instructions very carefully.

Carefully follow your doctor's instructions about when to increase your dose. Taking more solriamfetol than prescribed will not make it more effective and may result in serious side effects.

Your blood pressure and heart rate will need to be checked often.

Solriamfetol may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Do not change your dose or stop taking Sunosi without your doctor's advice.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover Sunosi. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, follow disposal instructions in the Medication Guide provided with your medicine.

Usual Adult Dose for Narcolepsy:

Initial dose: 75 mg orally once a day upon awakening
-Dose may be doubled after 3 days based on efficacy and tolerability
Maintenance dose: 75 to 150 mg orally once a day
Maximum dose: 150 mg/day

Comments:
-Doses above 150 mg/day have not been shown to increase effectiveness enough to outweigh dose-related adverse reactions.

Use: To improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

Initial dose: 37.5 mg orally once a day upon awakening
-Dose may be doubled at intervals of 3 days based on efficacy and tolerability
Maintenance dose: 37.5 to 150 mg orally once a day
Maximum dose: 150 mg/day

Comments:
-This drug does not treat the underlying airway obstruction in obstructive sleep apnea (OSA).
-Prior to initiating therapy, patients should have their underlying airway obstruction treated (e.g. with continuous positive airway pressure) for at least 1 month and should continue treatment while taking this drug.
-Doses above 150 mg/day have not been shown to increase effectiveness enough to outweigh dose-related adverse reactions.

Use: To improve wakefulness in patients with excessive daytime sleepiness associated with OSA.

If you have sleep apnea, this condition should be treated for at least 1 month before you start taking Sunosi.

Do not use Sunosi if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart problems;

• a heart attack or stroke;

• high blood pressure;

• diabetes;

• high cholesterol;

• kidney disease;

• mental illness, psychosis, bipolar disorder; or

• alcoholism or drug addiction (especially addiction to cocaine or other stimulant).

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of solriamfetol on the baby.

Tell your doctor if you are breastfeeding. Tell your doctor if you notice agitation, sleep problems, decreased appetite, or decreased weight gain in the nursing baby.

Sunosi is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but only if you plan to be awake for at least 9 hours. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking this medicine within 9 hours of when you plan to go to bed, or you may have trouble sleeping.

Get emergency medical help if you have signs of an allergic reaction to Sunosi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• racing thoughts, increased energy, decreased need for sleep, feeling agitated or irritable;

• ongoing sleep problems;

• fast or pounding heartbeats; or

• severe headache, blurred vision, pounding in your neck or ears.

Common Sunosi side effects may include:

• trouble sleeping;

• anxiety;

• nausea, loss of appetite; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with solriamfetol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.