Sunosi

Sunosi

What is Sunosi?

Sunosi does not treat sleep apnea. Continue to use your CPAP machine or other device prescribed by your doctor.

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

Warnings

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

Sunosi is a federally controlled substance because it contains solriamfetol. This drug may be a target for people who abuse prescription medications or street drugs.

Store Sunosi in a safe place to protect it from theft. Never give your Sunosi to anyone else as this may result in death or harm to the person. Selling or giving this medicine may harm others and is a violation of the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medications, or street drugs.

Before you take this medicine

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 taken an MAO inhibitor in the last 14 days.Dangerous drug interactions could occur. MAOIs 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 stimulants).

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 breast-feeding. Tell your doctor if you notice restlessness, trouble sleeping, decreased appetite, or decreased weight gain in your breastfed baby.

Sunosi is not approved for use by anyone under 18 years of age.

How should I take Sunosi?

Take Sunosi exactly as your doctor has told you. Follow all instructions on your prescription label and read any medication guides or instructions for use. Your doctor may occasionally change your dose.

Sunosi is usually taken once daily upon waking.

You can 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 does not increase effectiveness and may cause serious side effects.

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

Solriamfetol can be habit forming.Abuse can lead to addiction, overdose or death.Store the medication in a place where others cannot reach it. Selling or giving away this medicine is unlawful.

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

Store at room temperature, protected from moisture and heat. Keep track of your medications. You should be aware if someone uses it improperly or without a prescription.

Do not store leftover sunosi. Ask your pharmacist where there is a drug take-back program. If there is no take-back program, follow the disposal instructions in the medication guide that came with your medicine.

Dosage information

Usual Adult Dose for Narcolepsy:

Starting dose: 75 mg orally once daily upon awakening
– The dose can be doubled after 3 days depending on effectiveness and tolerability
Maintenance dose: 75 to 150 mg orally once daily
Maximum dose: 150 mg/day

Comments:
-Doses greater than 150 mg/day have not been shown to increase efficacy sufficiently to outweigh dose-related adverse effects.

Application: To improve alertness 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 daily upon awakening
– Depending on effectiveness and tolerability, the dose can be doubled every 3 days
Maintenance dose: 37.5 to 150 mg orally once daily
Maximum dose: 150 mg/day

Comments:
-This medication does not treat the underlying airway obstruction in obstructive sleep apnea (OSA).
-Before initiating therapy, patients should have their underlying airway obstruction treated (e.g. with continuous positive airway pressure) for at least one month and continue treatment while taking this medication.
-Doses greater than 150 mg/day have not been shown to increase efficacy sufficiently to outweigh dose-related adverse effects.

Application: To improve alertness in patients with excessive daytime sleepiness associated with OSA.

What happens if I miss a dose?

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

What happens if I overdose?

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

What to avoid

Avoid taking this medication within 9 hours of your planned bedtime, otherwise sleep disturbances may occur.

Sunosi side effects

If necessary, get emergency medical helpSigns of an allergic reaction to Sunosi:hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Call your doctor immediately if you have:

• racing thoughts, increased energy, decreased need for sleep, restlessness or irritability;

• persistent sleep problems;

• fast or pounding heartbeat; or

• severe headache, blurred vision, throbbing in the neck or ears.

Common side effects of Sunosi may include:

• sleep disorders;

• Fear;

• 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 can report side effects to FDA at 1-800-FDA-1088.

What other medications affect Sunosi?

Other medications may interact with solriamfetol, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.