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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
135
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)
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Improvement of the Clinical Global Impression (CGI) score
Time frame: At day 84 (visit 5)
Illness severity and average change during the study
Time frame: 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
Time frame: At day 1 (baseline), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)
Patient satisfaction questionnaire
Time frame: At day 84 (visit 5)
Safety evaluation via Adverse events reported
Time frame: At day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)
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