Evaluation of A Morning Dosing Of A New Medicine And Its Effects On Sleep At Bedtime 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:	May 2006
End Date:	July 2007

A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of Morning Administration of GW679769 (10mg and 30 mg) on Polysomnograph Sleep Recordings, Subjective Sleep Assessment, Daytime Cognition and Psychomotor Function in Subjects With Primary Insomnia

This study is designed to determine whether morning doses of GW679769, taken daily for 1 to 9
days, will promote sleep during the following night without significant post-dose thinking
impairment and drowsiness in subjects with primary insomnia.

Inclusion criteria:

- Difficulty going to sleep and/or staying asleep during 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, nightshift/rotating shift
work, frequent napping or planned travel across >2 time zones.

- Use to moderate use of nicotine, caffeine and alcoholic products.

We found this trial at

sites

GSK Investigational Site

Hinesville, Georgia 31313

from

Hinesville, GA