FDA Approves Hetlioz for the Treatment of Non-24-Hour Sleep-Wake Disorder

February 7, 2014
Melanie Sena

Melanie Sena is community editor of Pharmaceutical Technology.

Vanda Pharmaceuticals receives approval from FDA for Hetlioz for the treatment of Non-24.

Vanda Pharmaceuticals reported that FDA has approved Hetlioz (tasimelteon) 20 mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).  Hetlioz is the first FDA approved medication for Non-24.

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. Vanda anticipates making Hetlioz commercially available in the second quarter of 2014.

Source: Vanda Pharmaceuticals