Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in patients with primary insomnia: A multicenter, randomized, double-blind, placebo-controlled trial.

ABSTRACT:

Background

Tasimelteon is a dual melatonin 1 and melatonin 2  receptor agonist. Tasimelteon is the first and only approved medicine to treat a circadian rhythm disorder. In this Phase III trial, the efficacy and safety of tasimelteon was studied in primary insomnia characterized by difficulty falling asleep.

Trial design

A randomized, double-blind, placebo-controlled, multi-center study investigated 20 mg or 50 mg tasimelteon vs placebo in 322 patients with primary insomnia over a 5-week double-blind treatment interval using polysomnography(PSG) measures of sleep.

Methods

Patients underwent PSGs on Nights 1, 8, 22 and 29. Entry criteria emphasized enrollment of primary insomnia patients with a confirmed difficulty falling asleep. Subjective sleep latency was ≥ 45 minu

SUBMITTER: Synnott NC 

PROVIDER: S-EPMC12449008 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature