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

Astellas

Status and phase: Completed; Phase 4

Conditions: Sleep Initiation and Maintenance Disorders; Insomnia

Treatments: Drug: zolpidem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00653562

6199-JC-0002

Details and patient eligibility

About

To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

Full 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 .

Enrollment: 11 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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11 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Drug: zolpidem