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Sleep Satisfaction and Psychomotor Performance of Adults (MORFEO CR)

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: March 31, 2010
Last updated: July 16, 2012
Last verified: July 2012

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

Condition Intervention Phase
Sleep Disorders Drug: ZOLPIDEM Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire) [ Time Frame: at Baseline, at V2 (26 +/- 2 days) ]

Secondary Outcome Measures:
  • Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale) [ Time Frame: at Baseline, at V2 (26 +/- 2 days) ]

Enrollment: 30
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMBIEN CR
AMBIEN CR 12.5 mg once daily immediately before bedtime or in elderly/hepatically impaired patients: 6.25 mg once daily immediately before bedtime
Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01097382

Investigational Site Number 10
Buenos Aires, Argentina
Investigational Site Number 1
C.a.b.a., Argentina
Investigational Site Number 4
C.a.b.a., Argentina
Investigational Site Number 6
C.a.b.a., Argentina
Investigational Site Number 2
Capital Federal, Argentina, C1181ACH
Investigational Site Number 3
La Plata, Argentina
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT01097382     History of Changes
Other Study ID Numbers: ZOLPI_L_04551
U1111-1116-9105 ( Other Identifier: UTN )
Study First Received: March 31, 2010
Last Updated: July 16, 2012

Additional relevant MeSH terms:
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on June 23, 2017