Stilnox Treatment in Elderly Patients With Insomnia

Study Overview
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Brief Summary
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Primary objective: 1. To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China Secondary objectives: To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China. To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China

Official Title
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A Multicentre Prospective, Open Label ,3 Weeks Phase IV Study to Evaluate the Efficacy and Safety in Elder Patients With Insomnia in China

Conditions
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Insomnia

Intervention / Treatment
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* Drug: Zolpidem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary out-patient insomniac patient defined by DSM-IV criteria Insomnia history lasted at least 3 months , this history must include a self-reported usual sleep latency of 30 minutes or more and either 3 or more awakenings per night on average or a usual total sleep time of ≤6.5 hours Exclusion Criteria: Usage of hypnotics within the previous 1-3 weeks before inclusion depending on the half-life of the hypnotics that would affect the study effect Concomitant usage of other hypnotics (benzodiazepines and Non-benzodiazepines) during the course if the study. Concomitant usage of the following Central Nervous System active medicine : antipsychotics , antidepressants ,anxiolytics, lithium and other psychotropic drugs. The score of Hamilton Depression Rating Scale (HAMD-24 ) more than 17. The score of Hamilton Anxiety Rating Scale (HAMA-14 ) more than 14. Patients having known hypersensitivity to Stilnox or any of the ingredients in the products Patient with severe respiratory insufficiency Patients suffering from sleep apnoea syndrome Patients with known severe hepatic (risk of encephalopathy) and /or renal insufficiency, or other severe organ diseases Patients suffering from severe myasthenia gravis Patients with the previous history of drug abuse, drug dependence and drug addiction Any other disease state or major psychiatric condition that might affect study result The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>For 3 weeks | Drug: Zolpidem<br>* Administration of Zolpidem 5mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index (PSQI) score |  | At 1 week versus baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index score |  | At 3 weeks versus baseline | 
| Subject sleeping efficacy variable |  | At 1 week and 3 weeks versus baseline | 
| Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score |  | At 3 weeks versus baseline | 
| Adverse events (AE) and Serious adverse events (SAE) reports |  | Throughout the study period | 
| General Lab tests including hepatic and renal function |  | At 3 weeks versus baseline | 
| Vital signs |  | At 1 week and 3 weeks versus baseline |