Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

This study has been completed.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: February 6, 2007
Last updated: March 3, 2010
Last verified: March 2010
To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial

Condition Intervention Phase
Drug: Zolpidem (Myslee®)
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Mean daily sleep latency for double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean daily total hours of sleep [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Mean daily frequency of intermediate awaking [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Mean daily time of intermediate awaking [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Impression of patient for double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: February 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Zolpidem (Myslee®)
Other Names:
  • Myslee
  • FK199B
Experimental: 2 Drug: Zolpidem (Myslee®)
Other Names:
  • Myslee
  • FK199B
Placebo Comparator: 3 Drug: placebo


Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00432198

Chubu region, Japan
Chugoku region, Japan
Hokkaido region, Japan
Kansai region, Japan
Kanto region, Japan
Kyushyu region, Japan
Shikoku region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00432198     History of Changes
Other Study ID Numbers: 6199-JC-0001 
Study First Received: February 6, 2007
Last Updated: March 3, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Agonists
GABA-A Receptor Agonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 02, 2016