Generic Name and Formulations:
Tasimelteon 20mg; hard gel caps.
Vanda Pharmaceuticals, Inc.
Indications for HETLIOZ:
Treatment of non-24-hour sleep-wake disorder (Non-24).
Swallow whole. Take 20mg once daily before bedtime, at the same time every night. Do not take with food.
Risk of somnolence; can potentially impair the performance of activities requiring mental alertness. Severe hepatic impairment (Child-Pugh C): not recommended. Smokers. Elderly. Pregnancy (Cat. C). Nursing mothers.
Melatonin receptor agonist.
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.
Headache, increased ALT, nightmares or unusual dreams, upper respiratory tract infection, urinary tract infection; somnolence.