Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA

Study Overview
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Brief Summary
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Primary Objective: To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic insomnia at the prescription conditions of daily practice Secondary Objective: To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as needed basis.

Official Title
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Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) Administered on as Needed Basis in Patients With Chronic insomNIA

Conditions
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Sleep Disorders

Intervention / Treatment
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* Drug: ZOLPIDEM SL800750


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Primary insomnia diagnosis (difficulty for initiating sleep, or maintaining sleep to wake up to early in the morning, or to present a restless sleep) which causes clinically significant disturbances in the areas of social, work functioning or other important areas Exclusion criteria: Serious, severe and/or acute respiratory impairment Severe liver impairment Hypersensitivity to the formulation components or to some of its active metabolites Pregnant or breast-feeding women Patients with important associated disorders in SNC and specially psychotic disorders Patients with the probability of using alcoholic beverages concomitantly (as a precaution measure) Chronic use of benzodiazepines Moreover, in order to follow the international regulations in terms of the use and handling of hypnotic compounds, and to guarantee the appropriate study performance, no patients with one or more of the following characteristics should be included: Patients who cannot comply to follow-up Patients who have any drug abuse problem Individuals who work changing night shifts or with pathological snoring Presence (or suspicion) of sleep apnea, periodical legs movements or restless legs syndrome 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: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Zolpidem 12.5mg tablet at bed time during 12 weeks | Drug: ZOLPIDEM SL800750<br>* Pharmaceutical form: Zopidem 12.5 mg tablets Route of administration: Oral Dose regimen:One tablet at bed time and as needed (the patients choose which night they take the tablet without limit of number of nights)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of the Clinical Global Impression (CGI) score |  | At day 84 (visit 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Illness severity and average change during the study |  | At day 1 (baseline), day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5) | 
| Pittsburgh Sleep Quality Index (PSQI) score |  | At day 1 (baseline), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5) | 
| Patient satisfaction questionnaire |  | At day 84 (visit 5) | 
| Safety evaluation via Adverse events reported |  | At day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5) |