A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 64 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
Written informed consent has been obtained
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
Nervous System Diseases Zolpidem Central Nervous System Depressants
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives