Solriamfetol is used to treat excessive daytime sleepiness in adults with narcolepsy or in those whose sleep is disrupted by sleep apnea.

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

Solriamfetol may also be used for purposes not listed in this medication guide.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Solriamfetol is usually taken once daily when you wake up.

You may take solriamfetol with or without food.

You may need to swallow a solriamfetol 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 solriamfetol is against the law.

Do not change your dose or stop taking solriamfetol 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 solriamfetol. 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 solriamfetol.

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.
-Avoid taking within 9 hours of planned bedtime because of the potential to interfere with sleep if taken too late in the day.

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.
-Avoid taking within 9 hours of planned bedtime because of the potential to interfere with sleep if taken too late in the day.

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 solriamfetol.

Do not use solriamfetol 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.

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.

Solriamfetol 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Store solriamfetol in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets are left so you will know if any are missing.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid taking solriamfetol 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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Solriamfetol may cause serious side effects. 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 side effects of solriamfetol 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 affect 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.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Selling or giving away solriamfetol is against the law. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.