FDA Lowers Dose of Sleeping Pills to Prevent Drowsy Driving Crashes
In California and throughout the United States, many people use sleeping medications to help fight insomnia. According to a 2011 New York Times article, Americans filled an estimated 60 million prescriptions for sleep aids in the prior year as compared to just 47 million prescriptions in 2006. Many of these prescriptions were for Ambien or related brands with the same active ingredients, including Edluar, Zolpimist or generic drugs.
“While such medications may ensure a good night’s rest, their effects may last well into the morning hours, impairing drivers' ability to navigate the roads safely,” explained California car accident lawyer James Ballidis.
Sleep medications can have unintended consequences to the patients taking them. They may remain in the body and the blood stream at such a high level that they can impair driving ability in the morning. When a person takes Ambien or a related drug before bed, he or she could be less alert or less coordinated for a morning commute because the body has not been able to fully process the drug.
To tackle this problem, an announcement was made in January 2013 that the Food and Drug Administration (FDA) has ordered drug manufacturers to cut doses of the medications in half. This order was put into effect to change the doses administered to women, whose bodies tend to process the drug more slowly than their male counterparts. While the order only requires the change for women, however, the FDA is recommending that manufacturers apply the lower dosage requirements to all drugs, including those administered to men.
Under the new FDA rules, Ambien and other pills that had 10-milligram doses will now be lowered to 5-milligram doses. All regular strength Ambien pills and related products fell within this 10-milligram category. The extended release formulas will also be changed. Extended release drugs used to have 12.5 milligrams and will now have 6.25 milligrams.
The FDA advises that it is always best to prescribe the lowest dose possible to all patients, male or female. By lowering the dosage maximums, it will now be easier for doctors to prescribe smaller amounts of medication to patients, which will hopefully provide the same relief from sleep problems without putting the patients at risk the next morning.
Although Ambien and all sleep medications currently have warnings about drowsiness, there have still been high-profile driving accidents involving people who have taken sleeping pills. Two incidents in recent months involved celebrities Tom Brokaw, who was in an accident in September, and Kerry Kennedy, who got into a crash in July. In addition to these high profile cases, the FDA has also received at least 700 reports of crashes in recent years that can be tied to Ambien and other sleep medications containing zolpidem. Many of these reports could not be conclusively confirmed, however, because they often did not provide specifics on how much time had lapsed since the drug was taken.
What is clear is that there were accidents occurring and that the drug was taking longer to leave the body than had been anticipated. Although the medications are legal, a driver who causes an accident or who is found to be driving while under the influence can still be considered to be committing the crime of driving while impaired and may face criminal charges and civil actions.
With the new change to the FDA rules, hopefully fewer accidents will occur and motorists will be safer on their morning commutes.
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