Solriamfetol

Solriamfetol is a prescription medicine used to treat the symptoms of narcolepsy and obstructive sleep apnea.

• Solriamfetol is available under the following different brand names: Sunosi

Adult dosage

Tablet: Schedule IV

• 75mg
• 150mg

Narcolepsy

Adult dosage

• Initial: 75 mg orally once daily upon awakening
• Based on efficacy and tolerability, the dose may be doubled at intervals of at least 3 days; not to exceed 150 mg once daily
• Dosages more than 150 mg/day do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions

Obstructive Sleep Apnea

Adult dosage

• Initial: 37.5 mg orally once daily upon awakening
• Based on efficacy and tolerability, the dose may be doubled at intervals of at least 3 days; not to exceed 150 mg once daily
• Dosages more than 150 mg/day do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Solriamfetol include:

• headache,
• nausea,
• decreased appetite,
• insomnia, and
• anxiety.

Serious side effects of Solriamfetol include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• racing thoughts,
• increased energy,
• decreased need for sleep,
• feeling agitated or irritable,
• ongoing sleep problems,
• fast or pounding heartbeats,
• severe headache,
• blurred vision, and
• pounding in the neck or ears.

Rare side effects of Solriamfetol include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Solriamfetol has severe interactions with the following drugs:
  • isocarboxazid
  • linezolid
  • phenelzine
  • procarbazine
  • rasagiline
  • safinamide
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Solriamfetol has serious interactions with no other drugs.
• Solriamfetol has moderate interactions with at least 54 other drugs.
• Solriamfetol has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Coadministration with MAO inhibitors or within 14 days after discontinuing MAO inhibitor

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Solriamfetol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Solriamfetol?”

Cautions

• Blood pressure and heart rate increase
  • Increases systolic blood pressure, diastolic blood pressure, and heart rate in a dose-dependent fashion
  • Assess blood pressure and control hypertension before initiating treatment
  • Monitor blood pressure regularly during treatment and treat new-onset hypertension and exacerbations of preexisting hypertension
  • Caution in patients at higher risk of major adverse cardiovascular events (MACE), particularly patients with known cardiovascular and cerebrovascular disease, preexisting hypertension, and advanced age
  • If increases in blood pressure or heart rate cannot be managed with dose reduction or other appropriate medical intervention, consider discontinuation of therapy
• Psychiatric symptoms
  • Psychiatric adverse reactions observed during clinical trials, including anxiety, insomnia, and irritability
  • Caution in patients with a history of psychosis or bipolar disorders, as these patients were not evaluated in clinical trials
  • Patients with moderate or severe renal impairment may be at a higher risk of psychiatric symptoms because of the prolonged half-life
  • Observe patient for the possible emergence or exacerbation of psychiatric symptoms; reduce the dose or consider discontinuing drug if psychiatric symptoms develop
• Drug interaction overview
  • Drugs that increase blood pressure/heart rate: Caution; coadministration might result in pharmacodynamic interactions
  • Dopaminergic drugs: Caution; coadministration might result in pharmacodynamic interactions
  • MAO inhibitors
  • Contraindicated; do not use concomitantly or within 14 days after discontinuing MAO inhibitor
  • Coadministration of MAO inhibitors and noradrenergic drugs may increase the risk of a hypertensive reaction
  • Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure

Pregnancy and Lactation

• Available data from case reports are not sufficient to determine drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcome
• Pregnancy registry
  • Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-283-6220 or online at www.SunosiPregnancyRegistry.com
• Lactation
  • No data are available on the presence of solriamfetol or its metabolites in human milk, effects on breastfed infants, or effects on milk production
  • Solriamfetol is present in rat milk; when a drug is present in animal milk, the drug will likely be present in human milk
  • Clinical considerations: Monitor breastfed infants for adverse effects (eg, agitation, insomnia, anorexia, reduced weight gain)
  • The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition