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

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 Overview

• Status: Completed
• Conditions: Sleep Disorders
• Intervention / Treatment: Drug: ZOLPIDEM SL800750

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Col. Coyoacan, Mexico
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Zolpidem 12.5mg tablet at bed time during 12 weeks	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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Medical Affairs, Sanofi

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Estimate): October 5, 2010
• Last Update Submitted That Met QC Criteria: October 4, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: ZOLPI_L_04134