Official Title: “A Multicentre Prospective, Open Label ,3 Weeks Phase IV Study to Evaluate the Efficacy and Safety in Elder Patients With Insomnia in China”

Primary objective:

1. To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China

Secondary objectives:

1. To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China.

2. To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2007

Intervention(s) in this Clinical Trial

• Drug: Zolpidem
  • Administration of Zolpidem 5mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • For 3 weeks

Primary Measures

• Pittsburgh Sleep Quality Index (PSQI) score
  • Time Frame: At 1 week versus baseline
    Safety Issue?: No

Secondary Measures

• Pittsburgh Sleep Quality Index score
  • Time Frame: At 3 weeks versus baseline
    Safety Issue?: No
• Subject sleeping efficacy variable
  • Time Frame: At 1 week and 3 weeks versus baseline
    Safety Issue?: No
• Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score
  • Time Frame: At 3 weeks versus baseline
    Safety Issue?: No
• Adverse events (AE) and Serious adverse events (SAE) reports
  • Time Frame: Throughout the study period
    Safety Issue?: Yes
• General Lab tests including hepatic and renal function
  • Time Frame: At 3 weeks versus baseline
    Safety Issue?: No
• Vital signs
  • Time Frame: At 1 week and 3 weeks versus baseline
    Safety Issue?: No

Inclusion Criteria:

• Primary out-patient insomniac patient defined by DSM-IV criteria
• Insomnia history lasted at least 3 months , this history must include a self-reported usual sleep latency of 30 minutes or more and either 3 or more awakenings per night on average or a usual total sleep time of ≤6.5 hours

Exclusion Criteria:

• Usage of hypnotics within the previous 1-3 weeks before inclusion depending on the half-life of the hypnotics that would affect the study effect
• Concomitant usage of other hypnotics (benzodiazepines and Non-benzodiazepines) during the course if the study.
• Concomitant usage of the following Central Nervous System active medicine : antipsychotics , antidepressants ,anxiolytics, lithium and other psychotropic drugs.
• The score of Hamilton Depression Rating Scale (HAMD-24 ) more than 17.
• The score of Hamilton Anxiety Rating Scale (HAMA-14 ) more than 14.
• Patients having known hypersensitivity to Stilnox or any of the ingredients in the products
• Patient with severe respiratory insufficiency
• Patients suffering from sleep apnoea syndrome
• Patients with known severe hepatic (risk of encephalopathy) and /or renal insufficiency, or other severe organ diseases
• Patients suffering from severe myasthenia gravis
• Patients with the previous history of drug abuse, drug dependence and drug addiction
• Any other disease state or major psychiatric condition that might affect study result
• 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: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Bruno Jolain Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00359229

Study ID Number: ZOLPI_L_01540

ClinicalTrials.gov Identifier: NCT00359229

Health Authority: China: State Food and Drug Administration