Sunosi

What is Sunosi used for?

Sunosi is used to help you feel more awake if you are very sleepy during the day from sleep apnea or narcolepsy.

Description

SUNOSI contains solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI). Solriamfetol is a phenylalanine derivative with the systematic name (R)‑2-amino‑3‑phenylpropylcarbamate hydrochloride.

The molecular formula is C10H15N2O2Cl, and the molecular weight is 230.69.

The chemical structure is:

Solriamfetol hydrochloride is a white to off-white solid that is freely soluble in water.

SUNOSI tablets are intended for oral administration. Each 75 mg SUNOSI film‑coated tablet contains 75 mg solriamfetol (equivalent to 89.3 mg solriamfetol hydrochloride). Each 150 mg SUNOSI film‑coated tablet contains 150 mg solriamfetol (equivalent to 178.5 mg solriamfetol hydrochloride). The inactive ingredients are hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Mechanism of Action

The mechanism of action of solriamfetol to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea is unclear. However, its efficacy could be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor (DNRI).

Before taking Sunosi, tell your doctor:

• If you are allergic to Sunosi; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have high blood pressure.
• If you have kidney problems.
• If you have taken certain drugs for depression or Parkinson’s disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you are taking any of these drugs: Linezolid or methylene blue.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Sunosi with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Sunosi?

• Tell all of your health care providers that you take Sunosi. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine is not a cure for sleep problems and does not replace sleep. Stay under the care of your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Sunosi affects you. You may also need to avoid doing these things if you do not feel awake enough after taking Sunosi. If you still feel sleepy after taking Sunosi, talk with your doctor.
• This medicine may raise blood pressure and heart rate.
• High blood pressure can raise the chance of heart attack, stroke, or death from heart disease. If you have high blood pressure or heart disease, talk with your doctor.
• Check blood pressure and heart rate as the doctor has told you.
• This medicine has a risk of abuse and misuse. Use Sunosi only as you were told by your doctor. Tell your doctor if you have ever abused or been addicted to any drugs or alcohol.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Sunosi best taken?

Use Sunosi as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take Sunosi when you wake up.
• Take with or without food.
• Do not take Sunosi within 9 hours before bedtime. It may be harder to go to sleep if you take Sunosi too late in the day.
• Tablet may be broken in half.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is within 9 hours before bedtime, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Sunosi that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• A fast heartbeat.
• Mental, mood, or behavior changes that are new or worse.
• Trouble sleeping.

What are some other side effects of Sunosi?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach.
• Not hungry.
• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Sunosi?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

 75 MG 30-COUNT BOTTLE 

 

• NDC 68727‑350-01
• SUNOSI™
  (solriamfetol) tablets
• 75 mg                             CIV
  30 Tablets
• Rx Only
• Dosage and Use: See Package
  Insert.
• Each tablet contains 75 mg
  solriamfetol (equivalent to 89.3 mg
  of the hydrochloride salt)
• Store at 20°C to 25°C (68°F to 77°F);
  excursions permitted between
  15°C to 30°C (59°F to 86°F)
• Keep out of reach of children.
• Distributed by:
  Jazz Pharmaceuticals, Inc.
  Palo Alto, CA 94304

75 MG 100-COUNT BOTTLE

 

• NDC 68727‑350-02
• SUNOSI™
  (solriamfetol) tablets
• 75 mg                             CIV
  100 Tablets
• Rx Only
• Dosage and Use: See Package
  Insert.
• Each tablet contains 75 mg
  solriamfetol (equivalent to 89.3 mg
  of the hydrochloride salt)
• Store at 20°C to 25°C (68°F to 77°F);
  excursions permitted between
  15°C to 30°C (59°F to 86°F)
• Keep out of reach of children.
• Distributed by:
  Jazz Pharmaceuticals, Inc.
  Palo Alto, CA 94304

50 MG 30-COUNT BOTTLE

 

• NDC 68727‑351-01
• SUNOSI™
  (solriamfetol) tablets
• 150 mg                             CIV
  30 Tablets
• Rx Only
• Dosage and Use: See Package
  Insert.
• Each tablet contains 150 mg
  solriamfetol (equivalent to 178.5 mg
  of the hydrochloride salt)
• Store at 20°C to 25°C (68°F to 77°F);
  excursions permitted between
  15°C to 30°C (59°F to 86°F)
• Keep out of reach of children.
• Distributed by:
  Jazz Pharmaceuticals, Inc.
  Palo Alto, CA 94304

50 MG 100-COUNT BOTTLE

 

• NDC 68727‑351-02
• SUNOSI™
  (solriamfetol) tablets
• 150 mg                             CIV
  100 Tablets
• Rx Only
• Dosage and Use: See Package
  Insert.
• Each tablet contains 150 mg
  solriamfetol (equivalent to 178.5 mg
  of the hydrochloride salt)
• Store at 20°C to 25°C (68°F to 77°F);
  excursions permitted between
  15°C to 30°C (59°F to 86°F)
• Keep out of reach of children.
• Distributed by:
  Jazz Pharmaceuticals, Inc.
  Palo Alto, CA 94304

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else’s drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Sunosi is refilled. If you have any questions about Sunosi, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Sunosi or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition.

This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sunosi. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.