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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-03-31

Brief Summary

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To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

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Detailed Description

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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 .

Conditions

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Insomnia Sleep Initiation and Maintenance Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Patients will receive placebo in one part and zolpidem in the other part

Group Type EXPERIMENTAL

zolpidem

Intervention Type DRUG

Oral

Interventions

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zolpidem

Oral

Intervention Type DRUG

Other Intervention Names

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Myslee

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No