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News
A phase 3 trial finds tasimelteon (Hetlioz®) helps people with delayed sleep-wake phase disorder fall asleep significantly earlier. Patients on the drug fell asleep 42.5 minutes earlier on average, versus just 5.4 minutes for placebo. Vanda Pharmaceuticals plans to file for FDA approval for this new indication.
A phase 3 trial has shown that tasimelteon (Hetlioz®), a melatonin receptor agonist, significantly helps adults with delayed sleep-wake phase disorder (DSWPD) fall asleep earlier. In the 28-day study, participants were randomly assigned to receive tasimelteon 20mg or placebo once daily, with sleep onset tracked via sleep diary.
The results were notable: tasimelteon advanced sleep onset by an average of 42.5 minutes compared to just 5.4 minutes for placebo — a treatment difference of 37.1 minutes. The drug's safety profile was consistent with prior studies, and no new safety signals were identified.
By the Numbers:
Why it matters: DSWPD is a circadian rhythm disorder that can significantly impair daily functioning. Currently, tasimelteon is only approved for non-24-hour sleep-wake disorder and Smith-Magenis syndrome. With Vanda Pharmaceuticals planning to file a supplemental NDA, this trial could open the door to a new, targeted treatment option for DSWPD patients.
