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

Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00653562

Enrollment

Registered

2008-04-07

Start date

2006-11-30

Completion date

2010-03-31

Last updated

2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Sleep Initiation and Maintenance Disorders

Keywords

polysomnography, zolpidem, Sleep disorders, adolescent

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 .

Interventions

DRUGzolpidem

Oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Sleep latency	2 days

Secondary

Measure	Time frame
Total hours of sleep	2 days
Frequency of intermediate awaking	2 days
Time of intermediate awaking	2 days
Patient impression	2 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026