Stilnox Treatment in Elderly Patients With Insomnia (STEP)
Insomnia
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Experimental
1
For 3 weeks