Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Zolpidem

Criteria

Inclusion Criteria:

• patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10

• patients whose age at the time of obtaining consent is 12 years or over and 18 years or below

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