Insomnia
Conditions
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 elderly patients with insomnia in China. 2. To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China
Interventions
DRUGZolpidem
Administration of Zolpidem 5mg
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) score | At 1 week versus baseline |
Secondary
| Measure | Time frame |
|---|---|
| Subject sleeping efficacy variable | At 1 week and 3 weeks versus baseline |
| Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score | At 3 weeks versus baseline |
| Pittsburgh Sleep Quality Index score | At 3 weeks versus baseline |
| General Lab tests including hepatic and renal function | At 3 weeks versus baseline |
| Vital signs | At 1 week and 3 weeks versus baseline |
| Adverse events (AE) and Serious adverse events (SAE) reports | Throughout the study period |
Outcome results
None listed