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Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01024192
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : October 5, 2010
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Brief Summary:

Primary Objective:

To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic insomnia at the prescription conditions of daily practice

Secondary Objective:

To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as needed basis.

Condition or disease Intervention/treatment Phase
Sleep Disorders Drug: ZOLPIDEM SL800750 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) Administered on as Needed Basis in Patients With Chronic insomNIA
Study Start Date : November 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Zolpidem 12.5mg tablet at bed time during 12 weeks
Drug: ZOLPIDEM SL800750

Pharmaceutical form: Zopidem 12.5 mg tablets

Route of administration: Oral

Dose regimen:One tablet at bed time and as needed (the patients choose which night they take the tablet without limit of number of nights)

Primary Outcome Measures :
  1. Improvement of the Clinical Global Impression (CGI) score [ Time Frame: At day 84 (visit 5) ]

Secondary Outcome Measures :
  1. Illness severity and average change during the study [ Time Frame: At day 1 (baseline), day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5) ]
  2. Pittsburgh Sleep Quality Index (PSQI) score [ Time Frame: At day 1 (baseline), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5) ]
  3. Patient satisfaction questionnaire [ Time Frame: At day 84 (visit 5) ]
  4. Safety evaluation via Adverse events reported [ Time Frame: At day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5) ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- Primary insomnia diagnosis (difficulty for initiating sleep, or maintaining sleep to wake up to early in the morning, or to present a restless sleep) which causes clinically significant disturbances in the areas of social, work functioning or other important areas

Exclusion criteria:

  • Serious, severe and/or acute respiratory impairment
  • Severe liver impairment
  • Hypersensitivity to the formulation components or to some of its active metabolites
  • Pregnant or breast-feeding women Patients with important associated disorders in SNC and specially psychotic disorders
  • Patients with the probability of using alcoholic beverages concomitantly (as a precaution measure)
  • Chronic use of benzodiazepines

Moreover, in order to follow the international regulations in terms of the use and handling of hypnotic compounds, and to guarantee the appropriate study performance, no patients with one or more of the following characteristics should be included:

  • Patients who cannot comply to follow-up
  • Patients who have any drug abuse problem
  • Individuals who work changing night shifts or with pathological snoring
  • Presence (or suspicion) of sleep apnea, periodical legs movements or restless legs syndrome

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01024192

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Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Sponsors and Collaborators
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Study Director: Medical Affairs Sanofi

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT01024192    
Other Study ID Numbers: ZOLPI_L_04134
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: October 5, 2010
Last Verified: October 2010
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Sleep Disorders, Intrinsic
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Sleep Aids, Pharmaceutical
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