Sleep Satisfaction and Psychomotor Performance of Adults

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration

Secondary Objective:

To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Zolpidem

Criteria

Inclusion criteria:

• Patients consulting Psychiatrists (private or hospital) -whatever the reason for consulting- who present with chronic primary insomnia from the DSM IV (Diagnostic and Statistical Manual - Revision 4).

• Accepting to participate in the study and signing informed consent

Exclusion criteria:

• Pregnancy or breastfeeding.

• Current severe neuropsychiatric disorder (i.e. psychosis, obsessive compulsive disorder, major depression, dementia of Alzheimer or vascular type) according to DSM IV criteria.

• History of substance abuse or dependence (including alcohol) within the past year.

• Hypersensitivity to zolpidem or its excipients.

• Severe hepatic insufficiency

• Severe and/or acute respiratory insufficiency

• Myasthenia gravis.

• OTC (Over The Counter) sleep remedies or prescription sleep medications within 2 weeks or 5 half-life before screening.

• Severe medical illness.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.