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

Phase 4

Completed

• Conditions: Sleep Disorders
• Interventions: Drug: ZOLPIDEM SL800750

• Registration Number: NCT01024192
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-02
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-04
• Last Update Posted: 2010-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ZOLPIDEM SL800750	Zolpidem 12.5mg tablet at bed time during 12 weeks

Primary Outcome Measures

Name	Time	Method
Improvement of the Clinical Global Impression (CGI) score	At day 84 (visit 5)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇲🇽 Col. Coyoacan, Mexico