Stilnox Treatment in Elderly Patients With Insomnia (STEP)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Insomnia

Treatments: Drug: Zolpidem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00359229

ZOLPI_L_01540

Details and patient eligibility

About

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

Enrollment: 115 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

1

Experimental group

Description:

For 3 weeks

Treatment:

Drug: Zolpidem