Male and female healthy volunteers. Patients must also possess a full current driving license (for at least one year), and be a regular car driver.
The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 healthy male and female volunteers. The medications under investigation are eszopiclone and placebo. Volunteers 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
eszopiclone 3 mg
Placebo tablet
HPRU Medical Research Centre
Guildford, Surrey, United Kingdom
next day performance in a standardised test of car driving
Time frame: 9.5 hours post dose
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
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