FDA requires reduction of zolpidem in sleep aids

Prescriptions of sleep aids have exploded in the last decade, with nearly 60 million being given in 2011. Sleeping pills have become so popular that stories of Ambien based antics (cooking meals, sleep walking and sexual encounters without any memory of them the morning after) have become fodder for sketch comedies. However, drowsy driving has become such a hazard that is now rivaling distracted driving as a national public safety issue.

Essentially, the Food and Drug Administration (FDA) has received complaints that people taking sleep medications containing zolpidem would commonly be drowsy the morning after taking them, and such drowsiness would sometimes lead to car accidents.

In response, the FDA issued recommendations that dosages of sleep aids (specifically those with zolpidem as an active ingredient) should be reduced. The reasoning being that lower dosages would mean that less zolpidem would be in a person’s blood stream the next morning, which would reduce the likelihood of accidents caused by drowsy driving.

According to a New York Times report, the Agency has received nearly 700 complaints of impaired driving after taking zolpidem-based medications. However, researchers could not draw a distinct connection between the complaints and auto accidents because many users did not remember when they took their pills. However, a spike in complaints in 2007 (ostensibly caused by a change in labeling) led researchers to investigate dosing problems.

Researchers found that dosages for women should be cut if half, since zolpidem takes longer to dissipate in their systems compared to men, and that labeling should be changed to advise doctors to prescribe lower dosages for men.

Doctors believe that lower drowsy driving may ease the problem of drowsy driving while still being effective for patients.

Source: New York Times.com, FDA requires cuts to dosages of Ambien and other sleep drugs, January 11, 2013

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