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FDA Approves Hetlioz for Non-24-Hour Disorder

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The FDA today approved Hetlioz (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). Hetlioz, manufactured by Vanda Pharmaceuticals, treats the chronic circadian rhythm disorder that affects up to 70% of totally blind individuals. People with Non-24 experience nighttime sleep problems and a wide range of daytime difficulties, including the overwhelming urge to sleep during the day.

Hetlioz will be available in the second quarter of 2014 and may be able to provide a much needed treatment option to the estimated 80,000 totally blind Americans living with Non-24.

The most common adverse reactions in the clinical trials were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. 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