The FDA has approved Hetlioz (tasimelteon; Vanda) capsules, the first treatment for non-24-hour sleep-wake disorder (Non-24) in blind patients.

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Tasimelteon is a melatonin receptor agonist at MT1 and MT2 receptors. These receptors are thought to be involved in the control of circadian rhythms. The precise mechanism by which tasimelteon exerts its therapeutic effect in patients with non-24-hour sleep-wake disorder is unknown.

The approval of Hetlioz was based on two major efficacy studies. In these trials, treatment with Hetlioz resulted in significant improvement in increasing nighttime sleep and decreasing daytime sleep duration as compared to placebo.

Hetlioz will be available as 20mg capsules in 30-count bottles. It is expected to launch in the second quarter of 2014.

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