A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients

Phase 4

Completed

• Conditions: Sleep Initiation and Maintenance Disorders; Primary Insomnia
• Interventions: Drug: Zolpidem MR; Drug: Estazolam

• Registration Number: NCT00956319
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-08-09
• Study First Submitted QC: 2009-08-09
• Study First Posted: 2009-08-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-05
• Last Update Posted: 2011-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zolpidem group	Zolpidem MR	-
Estazolam group	Estazolam	-

Primary Outcome Measures

Name	Time	Method
Total score of Pittsburgh Sleep Quality Index (PSQ)	3 weeks

Secondary Outcome Measures

Name	Time	Method
Physician's clinical global impression (CGI)	3 weeks
Patient's global impression (PG)	3 weeks
Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary	3 weeks
Incidence and severity of adverse events, including abnormal sleep behavior	3 weeks