Effects of TS-142, a novel dual orexin receptor antagonist, on sleep in patients with insomnia: a randomized, double-blind, placebo-controlled phase 2 study.

ABSTRACT:

Rationale

Novel compound with potent antagonistic activity against orexin receptors may be new treatment option for patients with insomnia.

Objective

The aim was to investigate the efficacy and safety of single oral doses of the dual orexin receptor antagonist TS-142 in patients with insomnia.

Methods

This multicenter, double-blind, crossover randomized clinical trial included non-elderly patients with insomnia. Patients were randomized to receive single doses of placebo and TS-142 at doses of 5, 10, and 30 mg in one of four different sequences, with a 7-day washout period between treatments. Primary efficacy endpoints were latency to persistent sleep (LPS) and wake time after sleep onset (WASO) measured by polysomnography.

Results

Twenty-four patients were inc

SUBMITTER: Uchiyama M 

PROVIDER: S-EPMC9205809 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature