Sleep-wake disorders:

Indications for: HETLIOZ LQ

Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 3–15yrs of age.

Adult Dosage:

Not applicable.

Children Dosage:

<3yrs: not established. Take 1hr before bedtime, at the same time every night without food. 3–15yrs (≤28kg): 0.7mg/kg once daily; (>28kg): 20mg once daily.

HETLIOZ LQ 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 LQ Classification:

Melatonin receptor agonist.

HETLIOZ LQ 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:

NO

How Supplied:

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