Official Title: “FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-Blind, Group-Comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia -”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

• Drug: Zolpidem MR
  • Oral
• Drug: Zolpidem
  • Oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Mean wake time after sleep onset during the double-blind period
  • Time Frame: 2 Weeks
    Safety Issue?: No

Secondary Measures

• Mean total sleep time during the double-blind period
  • Time Frame: 2 Weeks
    Safety Issue?: No
• Mean number of nightly awakenings during the double-blind period
  • Time Frame: 2 Weeks
    Safety Issue?: No
• Mean sleep latency during the double-blind period
  • Time Frame: 2 Weeks
    Safety Issue?: No
• Patient impression during the double-blind period
  • Time Frame: 2 Weeks
    Safety Issue?: No
• Safety
  • Time Frame: 2 Weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Central Contact Study Chair Astellas Pharma Inc  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00283946

Study ID Number: 6199-CL-0007

ClinicalTrials.gov Identifier: NCT00283946

Health Authority: Japan: Ministry of Health, Labor and Welfare