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

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

Study Design: Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: August 2010

Intervention(s) in this Clinical Trial

• Drug: ZOLPIDEM SL800750
  • 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)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Zolpidem 12.5mg tablet at bed time during 12 weeks

Primary Measures

• Improvement of the Clinical Global Impression (CGI) score
  • Time Frame: At day 84 (visit 5)
    Safety Issue?: No

Secondary Measures

• 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)
    Safety Issue?: No
• 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)
    Safety Issue?: No
• Patient satisfaction questionnaire
  • Time Frame: At day 84 (visit 5)
    Safety Issue?: No
• 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)
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Medical Affairs Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on September 01, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01024192

Study ID Number: ZOLPI_L_04134

ClinicalTrials.gov Identifier: NCT01024192

Health Authority: Mexico: Ethics Committee