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Primary objective:
1. To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | For 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zolpidem | Drug | Administration of Zolpidem 5mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) score | At 1 week versus baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index score | At 3 weeks versus baseline | |
| Subject sleeping efficacy variable | At 1 week and 3 weeks versus baseline | |
| Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Jolain | Sanofi | Study Director |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| At 3 weeks versus baseline |
| Adverse events (AE) and Serious adverse events (SAE) reports | Throughout the study period |
| General Lab tests including hepatic and renal function | At 3 weeks versus baseline |
| Vital signs | At 1 week and 3 weeks versus baseline |
| D001523 |
| Mental Disorders |