SUNOSI Dosage & Rx Info | Uses, Side Effects

Sunosi Generic Name & Formulations

Legal Class

CIV

General Description

Solriamfetol 75mg+, 150mg; tabs; +scored.

Pharmacological Class

Wakefulness-promoter.

How Supplied

Tabs—30, 100

Manufacturer

Axsome Therapeutics, Inc.

Generic Availability

Sunosi Indications

Indications

To improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).

Limitations of Use

Not for treating underlying airway obstruction in OSA. Ensure underlying airway obstruction is treated (eg, CPAP) for ≥1 month before initiation. Modalities to treat underlying airway obstruction should be continued during treatment with Sunosi. Sunosi is not a substitute for these modalities.

Sunosi Dosage and Administration

Adult

Take upon awakening; avoid within 9hrs of planned bedtime. Narcolepsy: initially 75mg once daily; usual range 75–150mg once daily. OSA: initially 37.5mg once daily; usual range 37.5–150mg once daily. For both: may double dose at intervals of ≥3 days; max 150mg once daily. Moderate renal impairment (eGFR 30–59mL/min/1.73m²): initially 37.5mg once daily; may increase to max 75mg once daily after ≥7 days. Severe renal impairment (eGFR 15–29mL/min/1.73m²): initially and at max 37.5mg once daily. ESRD (eGFR <15mL/min/1.73m²): not recommended.

Children

Not established.

Sunosi Contraindications

Contraindications

During or within 14 days of MAOIs.

Sunosi Boxed Warnings

Not Applicable

Sunosi Warnings/Precautions

Warnings/Precautions

Assess BP and HR regularly prior to initiation and during therapy. Patients with higher risk of cardiovascular events (esp. known cardio- or cerebrovascular disease, pre-existing hypertension, advanced age). Consider discontinuing if BP or HR increases unmanageable. History of psychosis or bipolar disorders. Monitor for emergence or exacerbation of psychiatric symptoms; consider dose reduction or discontinuation if develop. Abuse potential. Drug or alcohol abuse. Reevaluate periodically. Moderate or severe renal impairment: adjust dose. Elderly: use lower doses; monitor. Pregnancy. Nursing mothers: monitor infants.

Sunosi Pharmacokinetics

Elimination

Renal. Half-life: 7.1 hours.

Sunosi Interactions

Interactions

See Contraindications. May increase risk of hypertensive reaction with concomitant MAOIs. Caution with concomitant dopaminergic drugs or other drugs that increase BP and/or HR.

Sunosi Adverse Reactions

Adverse Reactions

Headache, nausea, decreased appetite, insomnia, anxiety, dry mouth, constipation.

Sunosi Clinical Trials

See Literature

Sunosi Note

Notes

Enroll pregnant patients in the Sunosi Pregnancy registry by calling (877) 283-6220.

Sunosi Patient Counseling