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Wednesday, November 23, 2011

FDA Approve Another Addictive Drug



I thought I was seeing things when I read this. The FDA, in their infinite wisdom, has just approved Intermezzo, the pill that... well, it basically knocks you out for the count.

Designed by Transcept Pharmaceuticals Intermezzo is for people who wake in the middle of the night. Slip it under your tongue and you'll be out like a light. It's basically the equivalent of stepping in to the ring with Iron Mike Tyson.

Intermezzo - nice brand name. I have a thing about brand-names, I briefly touch on it in my book.

Intermezzo is is interesting. Inter - (tr) to place (a body) in the earth; bury, esp with funeral rites. Mezzo - (a person having) a singing voice between soprano and alto. In music, an intermezzo (Italian, plural: intermezzi), in the most general sense, is a composition which fits between other musical or dramatic entities. Oh, and it's also a coffee so there may be some objections to the name at some point down the line.

The FDA had on two occasions previously refused to approve Intermezzo, their main worry being that people might get up and try to drive before the drug fully wears off. Studies clearly show that the drug badly impairs driving, and that this effect lasts longer in some people than in others. To get around this the manufacturers changed the labelling to state that the drug should only be taken when people have at least four hours of sleep time remaining. They also added, "Moreover, people should not take Intermezzo if they've been drinking alcohol or if they've taken other sleep aids."


A simple tweak of a label and the FDA give it a clean bill of health. Amazing aren't they?

The final three paragraphs from the WebMD website say it all really:

Intermezzo, like other sleeping pills, can cause serious side effects. These include getting out of bed not fully awake and being unaware of doing things or remembering you did them.

Activities reported to the FDA while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking. Alcohol or other sleep medicines increase the risk of doing such things.

And like other forms of zolpidem, Intermezzo is a controlled substance that can be abused or that can lead to drug dependence.
"...getting out of bed not fully awake and being unaware of doing things or remembering you did them."

Any defence lawyers out there, I feel a bank robbery coming on.

Ironically, after taking Seroxat for 6 years I now have a sleep disorder, I wake in the middle of the night and can never get back to sleep. In fact, I can fall asleep at inopportune moments too and in the past I have fallen asleep waiting to be served at a bar, on a bus and even a telephone box! Thank you GlaxoSmithKline.

Will I be sampling Intermezzo?  HAHA! Once bitten...

WHAT DO WE WANT?

A CURE FOR INSOMNIA

WHEN DO WE WANT IT?

Zzzzzzzzzzzzzzzzzzzzzzzzzzz


I'm left scratching my head at the logic of this approval. It's not a cure, it's merely papering over the cracks and I can guarantee that more cracks will appear, they always do with these drugs that act on the brain.

Nice job FDA.







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