FDA to require lower recommended dosages for sleep drugs. WashingtonPost.com, 1/10/2013.
The new edict will affect the labeling of drugs that contain zolpidem, a widely used ingredient in sleep aids. FDA officials settled on the new rules after driving simulations and laboratory studies showed that eight hours after taking the medication, as many as 15 percent of women and 3 percent of men still had enough of the drug in their systems to impair driving “to a degree that increases the risk of a motor vehicle accident.”
An even higher percentage of patients experienced a lack of mental alertness the morning after using extended-release zolpidem products, the agency found.
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There have been numerous incidents in recent years involving accidents caused by drivers allegedly under the influence of sleep medications. Last month, for example, a New Jersey man was sentenced to more than three years in prison for causing a fatal head-on collision while impaired by Ambien. In 2006, then-Rep. Patrick J. Kennedy (D-Mass.) faced charges after he crashed into a barricade near the Capitol in the middle of the night. He said he was disoriented from taking prescription drugs, including Ambien.
So because some amateurs took Ambien and didn’t go straight to bed, or mixed it with something and did strange things, or just happened to have that kind of brain or reaction, or who took it and didn’t pay attention to the warning to be sure you have a full 8 hours to process the drug, even if you wake up in fewer than 8 hours, those of us who suffer from a chronic lack of sleep or persistent, intractable insomnia [and there are many reasons for that but I'll get to that another day] will now get lower doses than we need to get the bare minimum of sleep because “a lack of mental alertness the morning after using extended-release zolpidem products” is more serious than a lack of alertness due to chronic insomnia. Having a few nights of bad sleep is not insomnia. Having a few YEARS of bad, poor, not enough sleep is insomnia. And that kind of long-term insomnia is bad for your entire body and your short- and long-term health.
According to recent research by Matthew Walker, director of the Sleep and Neuroimaging Laboratory at the University of California, Berkeley, the amygdala—the part of the brain that alerts the body to be prepared in times of danger—goes haywire when a full night’s sleeplessness occurs. That in turn wreaks havoc on the prefrontal cortex, which controls our logical reasoning and “fight or flight” reflex, turning us, as Walker says, into “emotional Jell-O.” Memory capacity and speech control diminish; irritability spikes. At the same time, some studies have shown that cortisol, a hormone related to stress and depression and linked to cardiovascular disease, is building up in the body instead of being moderated by a good night’s rest. Concentration is kaput. The muscles ache. What’s worse, the external, ordinary dangers of modern life become many times more deadly: according to the U.S. Department of Transportation, there are about 200,000 car accidents a year caused by sleepy drivers, killing more people than drunk driving. Essentially robbed of its power to encode or consolidate memories after just one day, the brain quickly instead begins to mimic the profile of people with acute psychiatric disorders.
Is this the “fault” of folks who take Ambien or Ambien CR for sleep? Probably not, since it is very common for drug companies to do study after study until they get one with the results they want and they get to present that one, or those two, studies to the FDA to gain approval. Did the makers of Ambien not know about these, and other, side effects? Can anyone seriously think the answer to that is No? And if you’re going to take away an insomniac’s or fibromyalgia sufferer’s Ambien/zolpidem, what will help them sleep? And do any of you sleeping-at-night motherfuckers care?
