Sleep-wake disorders:

Indications for: DAYVIGO

Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Adult Dosage:

Take immediately before bedtime, with (≥7hrs) remaining before the planned time of awakening. 5mg once per night; may increase to max 10mg once daily based on clinical response and tolerability. Concomitant weak CYP3A inhibitors or moderate hepatic impairment: max 5mg once daily. Effect may be delayed if taken with or soon after a meal.

Children Dosage:

Not established.

DAYVIGO Contraindications:

Narcolepsy.

DAYVIGO Warnings/Precautions:

CNS depression. Daytime impairment (including impaired driving w. 10mg dose). Monitor for somnolence. Discontinue immediately if any complex sleep behaviors develop. Compromised respiratory function (eg, moderate to severe COPD, mild to severe obstructive sleep apnea). Suicidal ideation or behavior. Depression. Monitor for worsening insomnia or new cognitive/behavioral abnormalities. Reevaluate if unresponsive after 7–10 days of treatment. Severe renal or mild hepatic impairment: possible increased risk of somnolence. Severe hepatic impairment: not recommended. Drug or alcohol abusers. Elderly. Pregnancy. Nursing mothers.

DAYVIGO Classification:

Orexin receptor antagonist.

DAYVIGO Interactions:

Avoid alcohol. Potentiates CNS depression with other CNS depressants (eg, benzodiazepines, opioids, tricyclic antidepressants, alcohol); may need to adjust doses. Concomitant strong or moderate CYP3A inhibitors (eg, itraconazole, clarithromycin, fluconazole, verapamil); avoid. Concomitant weak CYP3A inhibitors (eg, chlorzoxazone, ranitidine); reduce dose (see Adults). Antagonized by strong or moderate CYP3A inducers (eg, rifampin, carbamazepine, St. John's wort, bosentan, efavirenz, etravirine, modafinil); avoid. Antagonizes CYP2B6 substrates (eg, bupropion, methadone); consider increasing dose of substrates.

Adverse Reactions:

Somnolence/fatigue, headache, nightmare/abnormal dreams; complex sleep-related behaviors (eg, sleep-walking, sleep-driving), sleep paralysis, hypnagogic hallucinations, cataplexy-like symptoms.

Metabolism:

Primarily metabolized by CYP3A4, and to a lesser extent by CYP3A5. The major circulating metabolite is M10.

Drug Elimination:

Following administration of an oral dose, 57.4% of the dose was recovered in the feces and 29.1% in the urine (<1% as unchanged). The effective half-life for lemborexant 5 mg and 10 mg is 17 and 19 hours, respectively.

Generic Drug Availability:

NO

How Supplied:

Tabs—30, 90