Sleep Satisfaction and Psychomotor Performance of Adults

National, Multicenter, Open Label, Phase IV, Before-after Design Study, in Adult Patients With Primary Insomnia to Evaluate Sleep Satisfaction and Psychomotor Performance After 1 Month of Treatment With Zolpidem CR (Ambien®CR) in 6 Sites in Argentina

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01097382

Acronym

MORFEO CR

Enrollment

Registered

2010-04-01

Start date

2010-03-31

Completion date

2011-04-30

Last updated

2012-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorders

Brief 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

Interventions

DRUGZOLPIDEM

Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)	at Baseline, at V2 (26 +/- 2 days)

Secondary

Measure	Time frame
Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)	at Baseline, at V2 (26 +/- 2 days)

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026