Effect of short-term treatment with gaboxadol on sleep maintenance and initiation in patients with primary insomnia.

Study Objective: To perform an early evaluation of the efficacy and safety of gaboxadol in the treatment of primary insomnia.

Methods: 26 adults (18-65 years) with DSM-IV criteria for primary insomnia were randomly assigned gaboxadol (5 mg, 15 mg) or placebo in a double-blind, crossover study. After a 3-night polysomnographic (PSG) screen, treatment was administered 30 min before bedtime on 2 consecutive nights during 3 separate sessions including PSG.