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Deconstructing a Full Prescribing Information: Part VIII Friday 2/3/12

Posted by smcgamer in Deconstucting The.
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Just now I realized I have more than four Deconstructing a Full Prescribing Information.  So I went over the same data twice in Part Five.  Oh well.

Onward nonetheless!

Insomnia again

Insomnia again (Photo credit: Foodie In Disguise)

Chronic Insomnia

The effectiveness of LUNESTA was established in five controlled studies in chronic insomnia.  Three controlled studies were in adult subjects, and two controlled studies were in elderly subjects with chronic insomnia.

Ah, chronic insomnia.  Guaranteed to waste thousands of hours a year!®©all rights reserved


In the first study, adults with chronic insomnia (n=308) were evaluated in a double-blind parallel-group trial of 6 weeks’  duration comparing LUNESTA 2 mg and 3 mg with placebo.

The (n=308) seems to mean that the group contained 308 adults with chronic insomnia.  If they each miss 4 hours of sleep per night, that’s 1 month 20 days of lost sleep per night!

Ahem… right.  Anyway, a double-blind study is a study in which neither the doctors or the patient know that they’re taking Lunesta.  This is to offset the placebo effect – where thinking about feeling better actually makes you feel better.  A parallel-group study is where two separate groups get two different medicines.

Objective endpoints were measured for 4 weeks.

From what I can find, an objective endpoint seems to be about tracking the results after going off of a medicine.

Both 2 mg and 3 mg were superior to placebo on LPS at 4 weeks.  The 3 mg dose was superior to placebo on WASO.

Ball-and-stick model of the (S)-zopiclone (esz...

Image via Wikipedia

Placebo, as mentioned above, is a pill that does nothing.  But the patient who doesn’t know he’s getting placebo thinks it’s working, and feels better for it.  As for LPS, the only thing I could find was lipopolysaccharide, and I doubt that’s correct.  WASO seems to mean wake after sleep onset – waking up in the middle of the night.

So Lunesta beats placebo, and 3 milligrams of it stops you from waking up at night, at least better than placebo would.

In the second study, adults with chronic insomnia (n=788) were evaluated using subjective measures in a double-blind, parallel-group study comparing the safety and efficacy of LUNESTA 3 mg with placebo administered nightly for 6 months.  LUNESTA was superior to placebo on subjective measures of sleep latency, total sleep time, and WASO.

This time, 788 adults were studied.  Subjectivity is the opposite of objectiveness – it’s where a person lets their emotions and opinions show a little more than objectivity – where facts and truth matter.  Efficacy is the ability for something to produce an effect – in this case, aiding sleep.  Sleep latency is how long it takes one to get to sleep after going to bed.

So LUNESTA was shown to work better than placebo in getting to sleep, staying asleep, and being asleep for long enough to feel rested.

So that’s it for tonight.  I still can’t believe I repeated part five.  Oh well.  See you next time.


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