Official Title: “Single Blind, Multi-Center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography”

To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Single Blind (Subject), Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2010

The study consists of two parts. All patients will receive placebo in one part and Zolpidem in the other part in a single blind manner. Efficacy will be measured with polysomnography .

Intervention(s) in this Clinical Trial

• Drug: zolpidem
  • Oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Patients will receive placebo in one part and zolpidem in the other part

Primary Measures

• Sleep latency
  • Time Frame: 2 days
    Safety Issue?: No

Secondary Measures

• Total hours of sleep
  • Time Frame: 2 days
    Safety Issue?: No
• Frequency of intermediate awaking
  • Time Frame: 2 days
    Safety Issue?: No
• Time of intermediate awaking
  • Time Frame: 2 days
    Safety Issue?: No
• Patient impression
  • Time Frame: 2 days
    Safety Issue?: No

Inclusion Criteria:

• Patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10

Exclusion Criteria:

• Patients with schizophrenia or manic-depressive illness
• Patients with insomnia caused by physical diseases
• Patients having a history of hypersensitivity to zolpidem
• Patients with attention-deficit hyperactivity disorder

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Chair Astellas Pharma Inc  

Overall Contact: Clinical Development Administration Dep.  clinicaltrials_info@jp.astellas.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00653562

Study ID Number: 6199-JC-0002

ClinicalTrials.gov Identifier: NCT00653562

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency