If you've ever taken a prescription sleep aid the night before, you may experience that drowsy-can't-shake-the-zzz's feeling the next morning. The Food and Drug Administration is so concerned about the number of prescription sleep aid users that experience unshakable drowsiness the next morning, that they are requiring the pharmaceutical companies for the manufacture of sleep aids to decrease their recommended dosage.
Several studies have found that some patients who use prescription sleep aids are so drowsy the next morning that they face a higher risk of serious injury. The new research indeed shows that prescription sleep aids can remain in the bloodstream at levels that are so high that they interfere with alertness and coordination, leading to a greater risk of car accidents. One of te studies specifically looked at individuals who had taken Intermezzo, a sleep aid that can be taken in the middle of the night to help individuals get back to sleep. Overall, the results of the study showed that 33% of women and 25% of men had enough of the drug remaining in their systems 8 hours later that it interfered with their ability to function properly. When the dosage was cut in half, only 15% of women and 5% of men were still affected 8 hours later.
The FDA is ordering that dosage be lowered from 10 mg to 5 mg for women for regular sleeping aids, and 12.5 to 6.25 for extended sleeping aids. The FDA is also recommending that the dosage be lowered for men, but is not requiring it since it seems that women metabolize sleep aids slower than men do. The new dosage requirements apply to the drug zolpidem, which is the active ingredient in Ambien, Edluar, Zolpimist. Other drugs like Lunesta and Sonata won't be affected because they use a different active ingredient. The FDA says that it has received over 700 reports of driving-related problems connected to zolpidem over the years.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.