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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Taiwan, Inc.
• Treatments: Zolpidem

Criteria

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