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Deconstructing a Full Prescribing Information – Part IX Tuesday 2/21/12

Posted 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.

Medicine drugs

Image via Wikipedia


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!


Image via Wikipedia


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