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Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: January 19, 2007
Last updated: April 3, 2009
Last verified: April 2009

The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5 mg in comparison with placebo, when administered over a long-term period, on an "as needed" basis, in patients with chronic primary insomnia.

Secondary objectives of the study are to evaluate the drug taking behavior over a long-term period and the clinical safety and tolerability of zolpidem-MR 12.5 mg in comparison to placebo administered over a long-term period, on an as needed basis.

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders Drug: zolpidem-MR (SL800750) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Long-Term Efficacy and Safety of Zolpidem-MR 12.5 mg Compared to Placebo, When Both Are Administered Over a Long-Term Period "as Needed", in Patients With Chronic Primary Insomnia

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The primary efficacy variable is item 1 (which assessed sleep aid) of the Patient Global Impression (PGI) scale at week 12.

Secondary Outcome Measures:
  • Main secondary variables are the Clinical Global Impression (CGI) improvement item and to items 2, 3, and 4 of the PGI scale at week 12.

Enrollment: 1025
Study Start Date: August 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with chronic primary insomnia

The investigator will evaluate whether there are other reasons why a patient may not participate.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00425243

United States, Pennsylvania
Malvern, Pennsylvania, United States, 19355
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00425243     History of Changes
Other Study ID Numbers: LTE5407
Study First Received: January 19, 2007
Last Updated: April 3, 2009

Keywords provided by Sanofi:
primary insomnia
chronic insomnia

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
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 September 21, 2017