Stilnox Treatment in Elderly Patients With Insomnia

Condition(s) targeted: Insomnia

Intervention: Zolpidem (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Bruno Jolain, Study Director, Affiliation: Sanofi-Aventis

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

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

Secondary outcome:

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

Vital signs

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

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.

Starting date: July 2006
Last updated: June 11, 2008