October 7, 2015
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How Supplied


HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).


The recommended dosage of HETLIOZ is 20 mg per day taken before bedtime, at the same time every night.

Because of individual differences in circadian rhythms, drug effect may not occur for weeks or months.

HETLIOZ should be taken without food [see CLINICAL PHARMACOLOGY] .


Dosage Forms And Strengths

Capsules: 20 mg size 1 dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white.

Storage And Handling

HETLIOZ 20 mg capsules are available as size 1, dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white, containing 20 mg of tasimelteon per capsule.

NDC 43068-220-01 Bottles of 30


Store HETLIOZ 20 mg capsules at controlled room temperature, 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect HETLIOZ 20 mg capsules from exposure to light and moisture.

Distributed by: Vanda Pharmaceuticals Inc. Washington, D.C. 20037 USA www.hetlioz.com. Revised: Dec 2014

Last reviewed on RxList: 12/29/2014
This monograph has been modified to include the generic and brand name in many instances.

How Supplied

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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