Sleeping pills are among the most widely prescribed medications in the United States. The FDA announced earlier this month that it will require the manufacturers of zolpidem, sold as Ambien and Edluar, to reduce recommended dosages because of concerns about morning drowsiness caused by the pills. The warning says the risk is especially high in women and that the recommended dosages should be halved when prescribed to women. The FDA has received 700 reports of the sleeping pill leading to “impaired driving ability and/or road traffic accidents.”
Researchers found that after eight hours, a 10mg dose of regular Ambien resulted in 15 percent of women and 3 percent of men having zolpidem levels high enough to cause next-morning impairment, which can negatively impact performance in tasks that require alertness, including driving. With extended release prescriptions, the results were similar but more staggering – 33 percent of women were found to have zolpidem levels high enough to cause next-morning impairment, compared to 25 percent of men.
The FDA is examining the effects of other sleeping pills and will require companies to do driving studies to determine if different dosing is needed for them as well. If you need more information contact Melissa Prickett, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com.
Sources: U.S. News Weekly and ABC News
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