Stilnox Treatment in Elderly Patients With Insomnia (STEP)

A Multicentre Prospective, Open Label ,3 Weeks Phase IV Study to Evaluate the Efficacy and Safety in Elder Patients With Insomnia in China

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

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Drug: Zolpidem

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; For 3 weeks	Drug: Zolpidem; Administration of Zolpidem 5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pittsburgh Sleep Quality Index (PSQI) score	At 1 week versus baseline

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Bruno Jolain, Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: July 31, 2006
• First Submitted That Met QC Criteria: July 31, 2006
• First Posted (Estimate): August 1, 2006

Study Record Updates

• Last Update Posted (Estimate): September 15, 2009
• Last Update Submitted That Met QC Criteria: September 14, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: ZOLPI_L_01540