Sleep-wake disorders:

Indications for: HETLIOZ

Non-24-hour sleep-wake disorder (Non-24) in adults. Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients ≥16yrs of age.

Adult Dosage:

Swallow caps whole. Take 1hr before bedtime, at the same time every night without food. 20mg once daily.

Children Dosage:

Non-24: not established. SMS: <16yrs: use susp form.

HETLIOZ Warnings/Precautions:

Caps and oral susp are not interchangeable. Risk of somnolence. Severe hepatic impairment (Child-Pugh C): not recommended. Smokers. Elderly. Pregnancy. Nursing mothers.

See Also:

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. Smoking or nighttime administration of beta-blockers may reduce tasimelteon effects. Additive effects with alcohol.

Adverse Reactions:

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

Generic Drug Availability:


How Supplied:

Caps—30; LQ—48mL, 158mL (w. bottle adapter, oral syringe)