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Solriamfetol

Medically reviewed by Drugs.com. Last updated on Jul 19, 2020.

Pronunciation

(SOL ri AM fe tol)

Index Terms

  • Solriamfetol Hydrochloride
  • Sunosi

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as hydrochloride:

Sunosi: 75 mg [scored]

Sunosi: 150 mg

Brand Names: U.S.

  • Sunosi

Pharmacologic Category

  • Dopamine and Norepinephrine - Reuptake Inhibitor

Pharmacology

The mechanism of action of solriamfetol is unclear, but its efficacy may be related to its activity as a selective dopamine and norepinephrine reuptake inhibitor (DNRI). Unlike traditional stimulants, it does not promote monoamine release (Baladi 2018).

Distribution

Vd: ~199 L

Metabolism

Minimal

Excretion

Urine (95% as unchanged drug)

Time to Peak

2 hours (fasting); delayed an additional 1 hour with high-fat meal

Half-Life Elimination

~7.1 hours

Protein Binding

Plasma: 13.3% to 19.4%

Special Populations: Renal Function Impairment

Half-life prolonged 1.2-fold (eGFR 60 to 89 mL/minute/1.73 m2), 1.9-fold (eGFR 30 to 59 mL/minute/1.73 m2), and 3.9-fold (eGFR <30 mL/minute/1.73 m2) in patients with renal impairment. AUC and half-life increased in patients with ESRD. An average of 21% of solriamfetol is removed by hemodialysis.

Use: Labeled Indications

Narcolepsy or obstructive sleep apnea: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).

Limitations of use: Solriamfetol is not indicated to treat the underlying airway obstruction in OSA. Patients should be treated for underlying airway obstruction for at least 1 month prior to and during therapy.

Contraindications

Concomitant use with or within 14 days of a monoamine oxidase (MAO) inhibitor

Dosing: Adult

Narcolepsy: Oral: Initial: 75 mg once daily; may increase based on response and tolerability at an interval of ≥3 days to the maximum dose of 150 mg/day.

Obstructive sleep apnea: Oral: Initial: 37.5 mg once daily; based on response and tolerability may double the dose at intervals of ≥3 days up to the maximum dose of 150 mg/day.

Dosing: Geriatric

Refer to adult dosing; consider use of lower doses.

Administration

Oral: Administer once daily upon awakening. Avoid administration within 9 hours of planned bedtime because of the potential to interfere with sleep.

Storage

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)

Drug Interactions

Anti-Parkinson Agents (Dopamine Agonist): Solriamfetol may enhance the adverse/toxic effect of Anti-Parkinson Agents (Dopamine Agonist). Monitor therapy

CNS Stimulants: May enhance the hypertensive effect of Solriamfetol. CNS Stimulants may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Hypertension-Associated Agents: Solriamfetol may enhance the hypertensive effect of Hypertension-Associated Agents. Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Solriamfetol. Avoid combination

Sympathomimetics: May enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Adverse Reactions

>10%: Central nervous system: Headache (16%)

1% to 10%:

Cardiovascular: Palpitations (2% to 3%), chest discomfort (≤2%), chest pain (<2%)

Central nervous system: Anxiety (4% to 6%), insomnia (5%), irritability (≤3%), jitteriness (≤3%), dizziness (2%), agitation (<2%), disturbance in attention (<2%), restlessness (<2%)

Dermatologic: Hyperhidrosis (≤2%)

Endocrine & metabolic: Increased thirst (<2%), weight loss (<2%)

Gastrointestinal: Decreased appetite (6% to 9%), nausea (7% to 8%), diarrhea (4%), xerostomia (3% to 4%), abdominal pain (3%), constipation (≤3%), bruxism (<2%), vomiting (<2%)

Neuromuscular & skeletal: Tremor (<2%)

Respiratory: Cough (<2%), dyspnea (<2%)

Frequency not defined: Cardiovascular: Increased diastolic blood pressure, increased heart rate, increased systolic blood pressure

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular effects: May cause dose-dependent increases in blood pressure and heart rate. Monitor heart rate and blood pressure prior to and regularly during treatment; control hypertension prior to initiating and during treatment. Avoid use in patients with unstable cardiovascular disease, serious heart arrhythmias, or other serious heart problems. Use caution in patients at high risk for cardiovascular events (eg, patients with known cardiovascular or cerebrovascular disease, preexisting hypertension, advanced age). If increases in blood pressure or heart rate cannot be managed with dose reduction of solriamfetol or other appropriate medical interventions, consider discontinuation of solriamfetol.

• Psychiatric effects: Psychiatric symptoms including anxiety, insomnia, and irritability have been reported with use. Use cautiously in patients with a history of psychosis or bipolar disorders; solriamfetol has not been studied with these populations. Monitor patients for emergence or exacerbation of psychiatric symptoms; if psychiatric symptoms develop reduce dose or discontinue.

Disease-related concerns:

• Substance abuse: Solriamfetol may have potential for abuse. Carefully evaluate patients for a recent history of drug abuse, especially stimulant or alcohol abuse, and monitor closely for signs of misuse or abuse.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Renal impairment: Use with caution in patients with renal impairment; dose adjustment required. Patients with moderate or severe renal impairment may be at higher risk of increased blood pressure, heart rate, and psychiatric symptoms due to the prolonged half-life in this population.

Monitoring Parameters

Blood pressure and heart rate (baseline and regularly during treatment)

Pregnancy Considerations

Adverse maternal and fetal events were observed in animal reproduction studies.

Data collection to monitor pregnancy and infant outcomes following exposure to solriamfetol is ongoing. Health care providers are encouraged to enroll females exposed to solriamfetol during pregnancy in the Sunosi Pregnancy Registry (877-283-6220 or www.SunosiPregnancyRegistry.com). Patients may also enroll themselves.

Patient Education

What is this drug used for?

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

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:

• Nausea

• Lack of appetite

• Diarrhea

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:

• Severe headache

• Dizziness

• Passing out

• Vision changes

• Fast heartbeat

• Mood changes

• Behavioral changes

• Trouble sleeping

• 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.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine 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 limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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