Vanda Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has approved HETLIOZ(TM) (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). HETLIOZ(TM) is the FDA approved medication for Non-24. Non-24 was described more than 60 years ago, and 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.

Non-24 affects the majority of totally blind individuals and it is estimated that approximately 80,000 Americans have the disorder. The approval of HETLIOZ(TM) was based on two key efficacy studies and the safety has been evaluated in over 1,300 individuals. The most common adverse reactions in the clinical trials were headache, increased alanine aminotransferase, nightmares or unusual dreams, upper respiratory or urinary tract infection.

After taking HETLIOZ(TM), patients should limit their activity to preparing for going to bed because HETLIOZ(TM) can impair the performance of activities requiring complete mental alertness.