Solriamfetol (sol-ri-AM-fe-tol)

Treats sleepiness caused by narcolepsy or sleep apnea.

Brand Name(s):

Sunosi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take the tablet when you first wake up in the morning. Do not use it within 9 hours of your planned bedtime. You may find it harder to go to sleep when you take the tablet too close to your bedtime.
• You may swallow the tablet whole or split it in half at the score line (middle of the tablet).
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Mixed unused medicine with dirt, used coffee grounds, or kitty litter, then place it in a sealable bag, empty can, or other container before throwing into the trash. Ask your pharmacist about the best way to dispose of medicine you do not use.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how solriamfetol works. Tell your doctor if you are using any medicine that may increase blood pressure or heart rate.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, breastfeeding, or planning to breastfeed, or if you have kidney disease, heart or blood vessel disease, high blood pressure, diabetes, high cholesterol, or a history of heart attack, stroke, or mental health problems.
• This medicine may cause the following problems:
  • High blood pressure and increased heartbeat
  • New or worsening changes in mood or behavior
• If you use a CPAP machine while you sleep, continue to use it. Solriamfetol is not a substitute for a CPAP machine.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, trouble sleeping, unusual mood or behavior
• Fast, pounding, or uneven heartbeat
• Feeling agitated, aggressive, confused, depressed, excited, or irritated
• Lightheadedness, dizziness, or fainting

If you notice these less serious side effects, talk with your doctor:

• Decreased appetite
• Headache
• Nausea

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088