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Comparison of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties (REST)

This study has been terminated.
(Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems)
Information provided by:
Sanofi Identifier:
First received: November 10, 2008
Last updated: August 27, 2009
Last verified: August 2009

The primary objective is to compare the potential for next-day residual effects of volinanserin 2 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties.

Secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders Drug: Volinanserin (M100907) Drug: Lormetazepam Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Safety and Efficacy of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties. A 4 Week,Randomized, Double-blind, Comparative, Parallel-group Study.

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Sleepiness in the morning measured on a visual analog scale of the patient's sleep questionnaire [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Other measure of next-day residual effects (ability to concentrate of the patient's sleep questionnaire) [ Time Frame: 4 weeks ]
  • Rebound effect measured by pr-WASO and pr-SOL on patient's sleep questionnaire during the run-out period [ Time Frame: 4 weeks ]
  • Subjective sleep parameters [ Time Frame: 4 weeks ]

Enrollment: 33
Study Start Date: November 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Volinanserin (M100907)
2 mg tablets QD
Active Comparator: 2 Drug: Lormetazepam
1 mg tablets (overencapsulated) QD


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Out-patients with Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria

Exclusion Criteria:

  • Based on patient's information, the patient has spent less than 6.5 hours or more than 9.0 hours, in bed, each night, over the preceding two weeks
  • Based on patient's information, the patient complains of less than one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
  • Disturbances of sleep maintenance parameters based on the patient's sleep questionnaire during the run-in period differing from pre-defined criteria.
  • Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
  • Night shift workers and individuals who nap 3 or more times per week
  • Consumption of xanthine-containing beverages (i.e., tea, coffee or cola) that comprises more than 5 cups or glasses per day

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00788515

Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00788515     History of Changes
Other Study ID Numbers: EFC10550
EudraCT: 2008-001492-30
Study First Received: November 10, 2008
Last Updated: August 27, 2009

Keywords provided by Sanofi:
sleep maintenance

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
MDL 100907
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents processed this record on September 21, 2017