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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Zolpidem 12.5mg tablet at bed time during 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZOLPIDEM SL800750 | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of the Clinical Global Impression (CGI) score | At day 84 (visit 5) |
| 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) |
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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:
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:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Affairs | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Col. Coyoacan | Mexico |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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) |
| D001523 | Mental Disorders |