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 Dosage:
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 Dosage:
Not established.
SUNOSI Contraindications:
During or within 14 days of MAOIs.
SUNOSI 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 Classification:
Wakefulness-promoter.
SUNOSI 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.
Drug Elimination:
Renal. Half-life: 7.1 hours.
Generic Drug Availability:
NO
How Supplied:
Tabs—30, 100
