Sleep-wake disorders:

Indications for HETLIOZ:

Treatment of non-24-hour sleep-wake disorder (Non-24).

Adult Dosage:

Swallow whole. Take 20mg once daily before bedtime, at the same time every night. Do not take with food.

Children Dosage:

Not established.

HETLIOZ Warnings/Precautions:

Risk of somnolence. Severe hepatic impairment (Child-Pugh C): not recommended. Smokers. Elderly. Pregnancy. Nursing mothers.

HETLIOZ Classification:

Melatonin receptor agonist.

HETLIOZ Interactions:

Avoid concomitant strong CYP1A2 inhibitors (eg, fluvoxamine), strong CYP3A4 inhibitors (eg, ketoconazole), or others; effects may be increased. Avoid concomitant strong CYP3A4 inducers (eg, rifampin) or others; effects may be reduced. Tasimelteon exposure decreased by smoking (induction of CYP1A2 levels). Additive effects with alcohol.

Adverse Reactions:

Headache, increased ALT, nightmares or unusual dreams, upper respiratory tract infection, urinary tract infection; somnolence.

Generic Drug Availability:

NO

How Supplied:

Caps—30