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



Status:Completed
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 64
Updated:10/14/2017
Start Date:January 2006
End Date:February 2007

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A 28 Day, Polysomnographic and Subjective Assessment of GW679769 for the Treatment of Primary Insomnia: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled Trial.

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.


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.
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