Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Midnight Pharma, LLC
• Treatments: Zolpidem

Criteria

Inclusion Criteria:

• Adult subjects (18-64 years) with a diagnosis of primary insomnia.

Exclusion Criteria:

• History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) axis I disorder other than primary insomnia.

• Sleep apnea, or restless legs syndrome.

• Daytime napping of more than 1 hour per day.

• Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.

• Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.