Stilnox Treatment in Elderly Patients With Insomnia

NCT00359229 | Completed Phase 4

• 1 other identifier: ZOLPI_L_01540
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

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. 1.To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China.
2. 2.To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI) score

  At 1 week versus baseline

Secondary Outcomes (6)

• 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

  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

Study Arms (1)

1

EXPERIMENTAL

For 3 weeks

Drug: Zolpidem

Interventions

Zolpidem DRUG

Administration of Zolpidem 5mg

1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bruno Jolain

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 31, 2006
• First Posted: August 1, 2006
• Study Start: July 1, 2006
• Primary Completion: September 1, 2007
• Last Updated: September 15, 2009

Record last verified: 2009-09