Deconstructing a Full Prescribing Information – Part IX Tuesday 2/21/12Posted by smcgamer in Uncategorized.
The studies continue!
In addition, a 6-period crossover PSG study evaluating eszopiclone doses of 1 to 3 mg, each given over a 2-day period, demonstrated effectiveness of all does on LPS, and of 3 mg on WASO. In this trial, the response was dose-related.
A polysomnograph study is a sleep study that monitors a person while they sleep. Things such as heart rate, brain activity, and eye movement are monitored. Once again, LPS refers to lipopolysaccharide (probably), and WASO is wake-after-sleep-onset; that is, waking up in the middle of the night.
Elderly subjects (ages 65-86) with chronic insomnia were evaluated in two double-blind, parallel-group studies, of 2 weeks duration. One study (n = 231) compared the effects of LUNESTA with placebo on subjective outcome measures, and the other (n = 292) on objective and subjective outcome measures. The first study compared 1 mg and 2 mg of LUNESTA with placebo, while the second study compared 2 mg of LUNESTA with placebo.
Remember that (n = 231) and (n = 292) indicated the size of the groups tested.
All doses were superior to placebo on measures of sleep latency. In studies, 2 mg of LUNESTA was superior to placebo on measures of sleep maintenance.
It works in the elderly, basically.
Up next is studies concerning safety. Buckets o’ fun!