Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography

Phase 4

Completed

• Conditions: Insomnia; Sleep Initiation and Maintenance Disorders
• Interventions: Drug: zolpidem

• Registration Number: NCT00653562
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

Detailed Description

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 .

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-07
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	zolpidem	Patients will receive placebo in one part and zolpidem in the other part

Primary Outcome Measures

Name	Time	Method
Sleep latency	2 days

Secondary Outcome Measures

Name	Time	Method
Time of intermediate awaking	2 days
Patient impression	2 days
Total hours of sleep	2 days
Frequency of intermediate awaking	2 days