Status:
COMPLETED
Stilnox Treatment in Elderly Patients With Insomnia
Lead Sponsor:
Sanofi
Conditions:
Insomnia
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00359229
Start Date
July 1 2006
Last Update
September 15 2009
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