HETLIOZ®

Overview

HETLIOZ®

HETLIOZ® is a melatonin receptor agonist. HETLIOZ® received U.S. Food and Drug Administration approval in January 2014 for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). HETLIOZ® received European Commision approval in July 2015 for the treatment of Non-24 in totally blind adults in the European Union.

Non-24 is a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle. The sleep disturbance causes significant distress or impairment in social, occupational and other important areas of functioning. Non-24 affects the majority of totally blind individuals and it is estimated that approximately 80,000 Americans have the disorder.

Full HETLIOZ® U.S. Prescribing Information can be found at: www.hetlioz.com.

For more information about HETLIOZ® call 1-844-HETLIOZ (1-844-438-5469).

Indication and Important Safety Information About HETLIOZ®

Indication

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

Important Safety Information

HETLIOZ® may cause somnolence: After taking HETLIOZ®, patients should limit their activity to preparing for going to bed, because HETLIOZ® can impair the performance of activities requiring complete mental alertness.

The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.

Use of HETLIOZ® should be avoided in combination with fluvoxamine or other strong CYP1A2 inhibitors, because of a potentially large increase in exposure of HETLIOZ®, and a greater risk of adverse reactions. HETLIOZ® should be avoided in combination with rifampin or other CYP3A4 inducers, because of a potentially large decrease in exposure of HETLIOZ®, with reduced efficacy.

There are no adequate and well-controlled studies of HETLIOZ® in pregnant women. Based on animal data, HETLIOZ® may cause fetal harm. HETLIOZ® should be used during pregnancy only if the potential benefit justifies the potential risks. Caution should be exercised when HETLIOZ® is administered to a nursing woman.

HETLIOZ® has not been studied in patients with severe hepatic impairment and is not recommended in these patients.

Safety and effectiveness of HETLIOZ® in pediatric patients have not been established.

Full HETLIOZ® Prescribing Information can be found at: www.hetlioz.com.

U.S. full prescribing information for HETLIOZ® is available at www.HETLIOZ.com.

HETLIOZ® is a registered trademark of Vanda Pharmaceuticals Inc.

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