Sleep-wake disorders:
Indications for HETLIOZ:
Treatment of non-24-hour sleep-wake disorder (Non-24).
Adult:
Swallow whole. Take 20mg once daily before bedtime, at the same time every night. Do not take with food.
Children:
Not established.
Warnings/Precautions:
Risk of somnolence. Severe hepatic impairment (Child-Pugh C): not recommended. Smokers. Elderly. Pregnancy. Nursing mothers.
Pharmacologic Class:
Melatonin receptor agonist.
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 Availability:
NO
How Supplied:
Caps—30
