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HETLIOZ
Sleep-wake disorders
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Drug Name:

HETLIOZ Rx

Generic Name and Formulations:
Tasimelteon 20mg; hard gel caps.

Company:
Vanda Pharmaceuticals, Inc.

Therapeutic Use:

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; 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.

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.

Pharmacological Class:

Melatonin receptor agonist.

Adverse Reactions:

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

How Supplied:

Caps—30

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