Stilnox Treatment in Elderly Patients With Insomnia
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia
Intervention: Zolpidem (Drug)
Phase: Phase 4
Sponsored by: Sanofi-Aventis
Official(s) and/or principal investigator(s):
Bruno Jolain, Study Director, Affiliation: Sanofi-Aventis
1. To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in
1. To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in
2. To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia
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
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Pittsburgh Sleep Quality Index (PSQI) score
Pittsburgh Sleep Quality Index score
Subject sleeping efficacy variable
Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score
Adverse events (AE) and Serious adverse events (SAE) reports
General Lab tests including hepatic and renal function
Minimum age: 65 Years.
Maximum age: N/A.
- 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
- 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
- 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.
Locations and Contacts
Starting date: July 2006
Last updated: June 11, 2008