The U.S. Food and Drug Administration has decided to require manufacturers of zolpidem, a popular sleeping pill, to reduced recommended doses for women by half amid concerns about lingering effects into the next day after they use the pill.
The drug, sold under names like Ambien, Ambien CR, Edular and Zolpimist, may remain in the system and affect the person’s alertness, especially while driving, even if they feel fully alert the next morning.
The FDA is requiring manufactures cut the dose for women from 10 mg to 5 mg for immediate-release drugs and 12.5 mg to 6.25 mg for extended-release products.
Even though the product has been on the market for nearly 20 years, the FDA said new data has prompted them to make the changes. The FDA has received about 700 reports of zolpidem and “impaired driving ability and/or road traffic accident.”
According to the administration, after a label change in 2007, they received many reports of driving issues associated with taking the medication and while the reports have been helpful in identifying a need to make a change, they said the reports were not specific enough in pinpointing the time of the accident, the dose or time zolpidem was taken or if any other substances was present in the driver’s blood at the time of the incident.
According to the FDA, “It was until FDA receivedthe new data on next-day blood levels and driving simulations, the apparent frequency of next-morning mental impairment was better identified.”
They hope to reduce next-morning impairment issues caused by taking the sleeping pills.
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