Official Title: “A Randomized, Open-Label, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Zolpidem Modified Release (MR) in Patients With Primary Insomnia”

The purpose of the study is to investigate the efficacy and safety of zolpidem modified release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary insomnia.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

• Drug: Zolpidem MR
  • oral
• Drug: Estazolam
  • oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Zolpidem group
• Active Comparator: Estazolam group

Primary Measures

• Total score of Pittsburgh Sleep Quality Index (PSQ)
  • Time Frame: 3 weeks
    Safety Issue?: No

Secondary Measures

• Physician's clinical global impression (CGI)
  • Time Frame: 3 weeks
    Safety Issue?: No
• Patient's global impression (PG)
  • Time Frame: 3 weeks
    Safety Issue?: No
• Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary
  • Time Frame: 3 weeks
    Safety Issue?: No
• Incidence and severity of adverse events, including abnormal sleep behavior
  • Time Frame: 3 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
• Written informed consent has been obtained

Exclusion Criteria:

• Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome
• Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem
• Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week)
• Patients who are pregnant, lactating or intend to become pregnant during the study period
• Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study
• Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
• Participation in any clinical trial within 1 month prior to randomization

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Chair Astellas Pharma Inc  

Overall Contact: Clinical Development Administration Department  clinicaltrials_info@jp.astellas.com

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00956319

Study ID Number: STCR-0802-TW

ClinicalTrials.gov Identifier: NCT00956319

Health Authority: Taiwan: Department of Health