Sleep Satisfaction and Psychomotor Performance of Adults (MORFEO CR)

Sanofi

Status and phase

Completed

Phase 4

Conditions

Sleep Disorders

Treatments

Drug: ZOLPIDEM

Study type

Interventional

Funder types

Industry

Identifiers

U1111-1116-9105 (Other Identifier)

ZOLPI_L_04551

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.