Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

Astellas

Status and phase: Completed; Phase 4

Conditions: Insomnia

Treatments: Drug: Zolpidem (Myslee®); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432198

6199-JC-0001

Details and patient eligibility

About

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

Enrollment: 122 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Oral

Treatment:

Drug: Zolpidem (Myslee®)

2

Experimental group

Description:

Oral

Treatment:

Drug: Zolpidem (Myslee®)

3

Placebo Comparator group

Description:

Oral

Treatment:

Drug: placebo