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

Astellas

Status and phase

Completed

Phase 4

Conditions

Sleep Initiation and Maintenance Disorders

Primary Insomnia

Treatments

Drug: Zolpidem IR

Drug: Zolpidem MR

Study type

Interventional

Funder types

Industry

Identifiers

NCT01181232

STCR-0901-TW

Details and patient eligibility

About

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.

Enrollment

132 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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