A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Zolpidem

Criteria

Inclusion Criteria:

• Clinical diagnosis of nonorganic insomnia.

• Must be able to swallow tablets

Exclusion Criteria:

• Allergic reactions to zolpidem (Myslee)

• Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.