Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00432198

Enrollment

122

Registered

2007-02-07

Start date

2007-02-28

Completion date

2010-01-31

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

Keywords

Insomnia, Zolpidem, Adolescent

Brief summary

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

Interventions

DRUGplacebo

Oral

DRUGZolpidem (Myslee®)

Oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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 * 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

Design outcomes

Primary

Measure	Time frame
Mean daily sleep latency for double-blind period	2 Weeks

Secondary

Measure	Time frame
Mean daily total hours of sleep	2 Weeks
Mean daily frequency of intermediate awaking	2 Weeks
Mean daily time of intermediate awaking	2 Weeks
Impression of patient for double-blind period	2 Weeks

Countries

Japan

Outcome results

None listed

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