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Deconstructing a Full Prescribing Information: Part VII Monday 2/28/11

Posted by smcgamer in Archive, Uncategorized.
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My blogging habits have been abysmal as of late.  With two bloggers writing here instead of one, however, posts should start coming faster.

Let us continue with part seven.

CLINICAL TRIALS

2D structure of eszopiclone (Lunesta)

Image via Wikipedia

The effect of LUNESTA on reducing sleep latency and improving sleep maintenance was established in studies with 2100 subjects (ages 18-86) with chronic and transient insomnia in six-placebo controlled trials of up to 6 months duration.

Insomnia is the difficulty of falling or staying asleep.  Transient insomnia is insomnia that lasts for less than a week, chronic insomnia lasts for longer.  Just for laughs, the average number of patients per age would be 30.8 people per age, though the numbers are probably different.  Placebo is basically dummy medicine with no real effects.  It is used in clinical tests to determine if the drug is effective, or people just think it’s effective.

Two of these trials were in elderly patients (n=523).  Overall, at the recommended adult dose (2-3 mg) and elderly dose (1-2 mg), LUNESTA significantly decreased sleep latency and improved measures of sleep maintenance (objectively measured as wake time after sleep onset [WASO] and subjectively measured as total sleep time).

It worked.

Transient Insomnia

Healthy adults were evaluated in a model of transient insomnia (n=436) in a sleep laboratory in a double-blind, parallel-group, single-night trial comparing two doses of eszopiclone and placebo.  LUNESTA 3 mg was superior to placebo on measures of sleep latency and sleep maintenance, including polysomnographic (PSG) parameters of latency to persistent sleep (LPS) and WASO.

A double-blind experiment is a trial in which neither the doctor nor the people taking the trial know which one is the medication and which one is the placebo.  They also don’t know what the medicine is.

 

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