Sunosi

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.

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. Avoid taking Sunosi within 9 hours of your planned bedtime. If you take it too close to your bedtime, you may find it harder to go to sleep.
• You may take Sunosi with or without food.
• Depending on your prescribed dose, your healthcare provider may tell you to swallow your Sunosi tablet whole or split the Sunosi tablet in half at the score line in the middle of the tablet. 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.

Dispose of remaining, unused, or expired Sunosi by a medication take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations.

• If no take-back program or authorized collector is available, mix Sunosi with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets.
• Place the mixture in a container such as a sealed plastic bag and throw it away in the household trash.

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 (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 your Sunosi to anyone else, because it may cause death or harm. 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.

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our Sunosi price guide page for more information about the cost.

You may also be eligible for a Sunosi savings card, Sunosi coupon, or Sunosi copay card. Ask your doctor or pharmacist if you qualify.

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.

• The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
• For more information or to participate in the registry, call 1-877-283-6220 or go to www.SunosiPregnancyRegistry.com

Tell your doctor if you are breastfeeding. Sunosi passes into breastmilk. Ask your healthcare provider about the best way to feed your baby if you take Sunosi. 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.

Common Side Effects

The most common Sunosi side effects are:

• trouble sleeping;
• anxiety;
• nausea, loss of appetite; or
• headache.

Serious Side Effects

Sunosi may cause the following serious side effects.

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 healthcare provider should check your blood pressure before you start and during treatment with Sunosi.
• Your healthcare provider may decrease your dose or tell you to stop taking this medicine if you develop high blood pressure that does not go away during treatment.

Mental (psychiatric) symptoms, including anxiety, problems sleeping (insomnia), irritability, and agitation

Tell your healthcare provider if you develop anxiety, problems sleeping, irritability, or agitation. Your healthcare provider may change your dose or tell you to stop taking Sunosi if you develop side effects during treatment.

Allergic reactions

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

Notes

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.

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 the FDA at 1-800-FDA-1088.

Adult Dose of Sunosi 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.

Adult Dose of Sunosi 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).

• Before initiating therapy, patients should have their underlying airway obstruction treated (eg, 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.

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.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. Sunosi and some other medicines may affect each other, causing possible serious side effects. Especially tell your healthcare provider if you:

• Take a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Store Sunosi at room temperature between 68°F and 77°F (20°C and 25°C).

Store in a safe place, like a locked cabinet.

Keep out of the reach of children.

Active Ingredient: solriamfetolInactive Ingredients: hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, titanium dioxide, and talc.

Sunosi is distributed by Axsome Therapeutics, Inc., New York, NY 10007, and is a trademark of Axsome Therapeutics, Inc. or its affiliates.