A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia

Study Overview
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Brief Summary
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This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive psychosis.

Official Title
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FK199B (Zolpidem MR Tablet) Phase III Clinical Study - A Double-Blind, Crossover, Comparative Polysomnographic Study Using Zolpidem (Myslee®) as a Positive Control in Patients With Insomnia, Excluding Patients With Schizophrenia or Manic-Depressive Psychosis

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Drug: FK199B
* Drug: Zolpidem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is diagnosed as a primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Patients complaining of insomnia continuously for 4 weeks or longer Patient's usual bedtime is between 9 p.m. and 12 a.m. for the 4 week period prior to initial screening Patient on most occasions sleeps for a total of ≥3 and <6.5 hours over the 4 week period prior to initial screening Patient's usual wake time after sleep onset in a single night is ≥45 minutes per night for the 4 week period prior to initial screening Patients have a body weight of ≥45 kg and ≤85 kg, a BMI of ≥18.5 and <30 Exclusion Criteria: Patients with schizophrenia or manic-depressive psychosis Patients with insomnia caused by physical diseases including chronic obstructive pulmonary disease, bronchial asthma, fibrositis syndrome, chronic fatigue syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic Patients with circadian rhythm sleep disorder Patient works night shifts Patients with alcoholic sleep disorder Patients with alcohol or drug dependence or a history of these Patients with insomnia related with drugs including antiparkinson, antihypertensive, or steroid drugs Patients with sleep apnea syndrome Patients with restless legs syndrome or periodic limb movement disorder Patients with epileptic insomnia Patients smoke on average 40 or more cigarettes a day Patients who had received psychotropic drugs other than hypnotics (including anxiolytic or antidepressant drugs for hypnotic effect) within a 4 week period prior to the initial screening

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FK199B-first group<br> | Drug: FK199B<br>* oral<br>* Other names: Zolpidem MR Tablet;Drug: Zolpidem<br>* oral<br>* Other names: Myslee;|
| Experimental: Zolpidem-first group<br> | Drug: FK199B<br>* oral<br>* Other names: Zolpidem MR Tablet;Drug: Zolpidem<br>* oral<br>* Other names: Myslee;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings) |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sleep parameters estimated from polysomnography recording |  | 8 hours | 
| Sleep parameters estimated from sleep questionnaire |  | After each night of sleep during the study period | 
| Patient impression from sleep questionnaire |  | After each night of sleep during the study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FK199B, Zolpidem