Conditions: Primary Insomnia
Keywords: sleeplessness orexin receptor antagonist almorexant insomnia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 709
Healthy volunteers: no

Brief summary:
A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

Detailed description:

Arms:
arm 1: almorexant 200 mg arm 2: almorexant 100 mg arm 3: Placebo arm 4: zolpidem 10 mg

Interventions: intervention 1: almorexant intervention 2: almorexant intervention 3: Placebo intervention 4: zolpidem
Intervention descriptions: intervention 1: 2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem intervention 2: 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem intervention 3: 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem intervention 4: 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Protocol document: