FDA approves Hetlioz for Non-24-Hour Sleep Disorder-Vanda

The FDA has approved Hetlioz (tasimelteon) 20mg capsules, from Vanda Pharma, for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). Hetlioz is the first FDA approved medication for Non-24.

The approval was based on results from SET and RESET, two Phase III 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, patients should limit their activity to preparing for going to bed because the drug can impair the performance of activities requiring complete mental alertness.