The orexin antagonist SB-649868 promotes and maintains sleep in men with primary insomnia.

ABSTRACT:

Study objectives

To assess the acute effects of SB-649868 in male subjects with Primary Insomnia with regard to (1) objective and subjective sleep parameters, (2) safety and tolerability, (3) next-day residual effects.

Design

Multicenter, randomized, double-blind, placebo-controlled crossover study using a complete set of Williams orthogonal Latin Squares

Setting

9 sleep centers in Germany

Patients

52 male subjects with a diagnosis of primary insomnia (difficulty in sleep initiation and maintenance) confirmed by polysomnography

Interventions

SB-649868 (10, 30, 60 mg) and placebo administered after dinner 90 minutes before bedtime

Measurements and results

Sleep effects assessed by polysomnography during 2 consecutive nights and by sleep questionnai

SUBMITTER: Bettica P 

PROVIDER: S-EPMC3397789 | biostudies-literature | 2012 Aug

REPOSITORIES: biostudies-literature