Deconstructing a Full Prescribing Information: Part X

The greatest concern of all.

Studies Pertinent To Safety Concerns For Sedative/Hypnotic Drugs

Cognitive, Memory, and Sedative, and Psychomotor Effects

In two double-blind, placebo-controlled, single-dose cross-over studies of 12 patients each (one study in patients with insomnia; one with normal volunteers), the effects of LUNESTA 2 and 3 mg were assessed on 20 measures of cognitive function and memory at 9.5 and 12 hours after a nighttime dose.

A double-blind study is a study in which neither the patients or the doctors know that the patients are taking LUNESTA.  This is done to eliminate subjectivity and bias.  Placebo is a useless medication – it has no effect.  Placebo serves as the “control” of the experiment – the bottom of the scale to compare Lunesta’s effectiveness to.

Comparison of Double-Blind Placebo-Control Food Dye Challenge Studies (Photo credit: Wikipedia)

Although results suggested that patients receiving LUNESTA 3 mg performed more poorly than patients receiving placebo on a very small number of these measures at 9.5 hours post-dose, no consistent patterns of abnormalities was seen.

Essentially, some of the patients “performed more poorly” after 9.5 hours with Lunesta over placebo.  I’m not sure what “performed more poorly” quite means, though with the usual “don’t operate heavy machinery” warning, I guess I can suppose it’s something like that.

Up next: memory impairment!  Don’t worry, it’s not really that bad.  Was it?  I don’t remember.  *rimshot*

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