NEW DRUG APPROVALS Hetlioz for Non-24-Hour Sleep-Wake Disorder

NEW DRUG APPROVALS Hetlioz for Non-24-Hour Sleep-Wake Disorder The FDA has approved tasimelteon (Hetlioz, Vanda Pharmaceuticals) 20-mg capsules for the treatment of non-24-hour sleep-wake disorder. Tasimelteon is the first FDA-approved medication for this chronic, circadian rhythm disorder, which results from a misalignment of the endogenous master body clock to the 24-hour day that disrupts the sleep-wake cycle. The disorder affects an estimated 80,000 Americans, including most totally blind individuals. Tasimelteon’s approval was based on two key efficacy studies and its safety has been evaluated in more than 1,300 individuals. The most common adverse reactions in clinical trials were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. After taking tasimelteon, patients should limit their activity to preparing for bed: The drug can impair performance of activities that require complete mental alertness. Vanda expects to make the drug commercially available in the second quarter of 2014. Source: Vanda Pharmaceuticals, January 31, 2014