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

Condition(s) targeted: Sleep Initiation and Maintenance Disorders; Insomnia

Intervention: zolpidem (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc

Overall contact:
Clinical Development Administration Dep., Email: clinicaltrials_info@jp.astellas.com

To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

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

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

Primary outcome: Sleep latency

Secondary outcome:

Total hours of sleep

Frequency of intermediate awaking

Time of intermediate awaking

Patient impression

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 .

Minimum age: 12 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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

Clinical Development Administration Dep., Email: clinicaltrials_info@jp.astellas.com

Touhoku, Japan; Not yet recruiting

Kantou, Japan; Recruiting

Kansai, Japan; Recruiting

Kyusyu, Japan; Recruiting

Starting date: November 2006
Ending date: January 2010
Last updated: September 8, 2009