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

Phase 4

Completed

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

• Registration Number: NCT01181232
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2014-08
• Last Update Submitted: 2014-09-09
• Last Update Posted: 2014-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study
• 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
IR group	Zolpidem IR	-
MR low-dose group	Zolpidem MR	-
MR high-dose group	Zolpidem MR	-

Primary Outcome Measures

Name	Time	Method
Rest/activity cycles measured by Actigraphy	For 2 weeks (Day 0, Day 7, Day 14)
Total score of Pittsburgh Sleep Quality Index (PSQI)	For 2 weeks (Day 0, Day 7, Day 14)

Secondary Outcome Measures

Name	Time	Method
Physician's clinical global impression (CGI)	For 2 weeks (Day 0, Day 7, Day 14)
Day time function as assessed by Epworth Sleepiness Scale (ESS)	For 2 weeks (Day 0, Day 7, Day 14)
Patient's global impression (PGI)	For 2 weeks (Day 0, Day 7, Day 14)
Sleep latency as derived from sleep diary	For 2 weeks (Day 0, Day 7, Day 14)
Number of awakenings as derived from sleep diary	For 2 weeks (Day 0, Day 7, Day 14)
Wake time after sleep onset as derived from sleep diary	For 2 weeks (Day 0, Day 7, Day 14)
Total sleep time as derived from sleep diary	For 2 weeks (Day 0, Day 7, Day 14)