Sleep-wake disorders:

Indications for SUNOSI:

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.

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.

Contraindications:

During or within 14 days of MAOIs.

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.

Pharmacologic Class:

Wakefulness-promoter.

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.

Adverse Reactions:

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

Note:

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

Generic Availability:

NO

How Supplied:

Tabs—30, 100

Pricing for SUNOSI

150mg tablet (Qty: 30)
Appx. price $662
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