Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia

Phase 2

Completed

Brief Summary: This study is designed to find the optimal (best) doses of GW679769 that could be given daily to promote sleep onset and maintain sleep during the night without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.

Recruitment & Eligibility

Inclusion Criteria

Difficulty going to sleep and/or staying asleep for at least the past 3 months.
Insomnia must result in significant distress or impairment in functioning at home, socially or at work.
Otherwise good health with no significant or unstable medical disorder including psychiatric, neurological, endocrine, heart, lung or gastrointestinal disorders, drug/alcohol abuse, cognitive impairment, cancer or chronic pain conditions such as arthritis.

Exclusion Criteria

History of other sleep disorders such as sleep apnea or restless leg syndrome.
Regular sleep habits, including bedtime between 9 PM and midnight.
No nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.
Use of nicotine, caffeine and alcoholic products.

Primary Outcome Measures

Name	Time	Method
Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep.	28 Days

Secondary Outcome Measures

Name	Time	Method
Comparison of GW679769 and placebo effects on sleep maintenance and duration on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination.	28 Days

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial