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Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 24, 2006
Last Update Posted: February 22, 2012
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.
Information provided by (Responsible Party):
To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.

Condition Intervention Phase
Primary Insomnia Drug: Eszopiclone Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Single Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability and Psychomotor/Memory Function in Patients With Primary Insomnia Compared to Placebo

Resource links provided by NLM:

Further study details as provided by Sunovion:

Primary Outcome Measures:
  • next day performance in a standardised test of car driving [ Time Frame: 9.5 hours post dose ]

Secondary Outcome Measures:
  • Compensatory Tracking Task (CTT) [ Time Frame: 9.5 hours post dose ]
  • Rapid Visual Information Processing (RVIP) [ Time Frame: 9.5 hours post dose ]
  • Sternberg's Short-term Memory Scanning task (STM) [ Time Frame: 9.5 hours post dose ]
  • Critical Flicker Fusion (CFF) [ Time Frame: 9.5 hours post dose ]
  • Digit Symbol Substitution Test (DSST) [ Time Frame: 9.5 hours post dose ]
  • Choice Reaction Time (CRT) [ Time Frame: 9.5 hours post dose ]
  • Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales [ Time Frame: 9.5 hours post dose ]

Enrollment: 32
Study Start Date: April 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
eszopiclone 3 mg
Drug: Eszopiclone
eszopiclone 3 mg
Other Names:
  • S-Zopiclone
  • Lunesta
Placebo Comparator: 2
Placebo tablet
Drug: Placebo
Placebo tablet

Detailed Description:
The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 male and female primary insomnia patients. The medications under investigation are eszopiclone and placebo. Patients will receive the study medications and placebo on the evening of Day 2 of each treatment period. Performance will be assessed on Day 3 of each treatment period. Each treatment period will be separated by at least a 7-day washout period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged between 18 and 55 years inclusive
  • In good health as determined by a medical history, ECG, haematology, blood and urine biochemistry and physical examination by the doctor
  • Diagnostic and statistical manual of mental disorders, defined primary insomnia
  • A body mass index greater than or equal to 18 and less than or equal to 30
  • Registered with a general practitioner (GP)
  • Hold a full current driving licence for at least one year, and be regular car drivers

Exclusion Criteria

  • The use of any other medication during the study with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol. A 7-day washout period is required for any patient currently receiving prescription or non-prescription sleep medication.
  • Diagnosed sleep disorder or confirmed symptoms other than primary insomnia (e.g. restless leg syndrome, sleep apnoea)
  • Significant history of mental illness, significant drug allergy, malignancy or chronic drug abuse (including alcohol)
  • Any subject with known hypersensitivity to any of the study treatments
  • A sleep/wake cycle other than primary insomnia (e.g. shift work) liable to prejudice the results of the study
  • Pregnant or lactating females, and females of child bearing potential not using effective contraception
  • Patients who habitually smoke more than 5 cigarettes per day
  • Caffeine consumption of more than 5 cups or glasses per day
  • History of alcohol or drug dependence or intake of more than the equivalent of 14 units of alcohol per week for females and 21 units per week for males
  • Current participation in another clinical trial, or participation in a clinical trial within the last 90 days
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00368056

United Kingdom
HPRU Medical Research Centre, University of Surrey
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
  More Information

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00368056     History of Changes
Other Study ID Numbers: 190-060
First Submitted: August 23, 2006
First Posted: August 24, 2006
Last Update Posted: February 22, 2012
Last Verified: February 2012

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