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

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Eszopiclone; Zopiclone

Criteria

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