The Food and Drug Administration recently announced that it would be requiring manufacturers of several popular sleep medications to reduce the minimum recommended dose that is mentioned on the packaging of these drugs.
The active ingredient in many medications like Ambien, and Ambien CR is zolpidem. According to the Food and Drug Administration, studies show that high doses of zolpidem continue to remain in the bloodstream of persons even the next morning. This means that these persons may be at risk of impairment, when they’re driving or working. If the recommended dose of these drugs is reduced, fewer traces of zolpidem will be found in the blood in the morning, reducing the person’s risk of being involved in an accident.
The Food and Drug Administration has also identified that women seem to be at a much higher risk of such impaired driving because of traces of zolpidem in their systems. Women eliminate the drug much more slowly from their system. Therefore, the Food and Drug Administration, has informed the manufactures of these drugs, that the recommended dose for women must be lowered from 10 mg to 5 mg in the case of immediate-release products. These products include Ambien, Zolpimist and Edluar. In the case of extended-release products, the dosage must be reduced from 12.5 mg to 6.25 mg.
For men, the Food and Drug Administration has advised that the labeling should recommend that healthcare professionals consider prescribing lower doses.
The Food and Drug Administration is also asking the manufacturers of these drugs to inform patients about the risks of being impaired the next morning because of the continuing influence of these drugs. The risks are especially high when the person is indulging in an activity that would require a high state of alertness, like driving or working with machinery. These activities may be adversely impacted by the presence of the drug in the system.
The concerns of the Food and Drug Administration are not unwarranted. According to certain studies, the levels of zolpidem that remain in a person’s bloodstream the morning after the medication is taken are high enough to increase the risk of being involved in an auto accident. Several studies have been conducted, not just on driving simulators but also in controlled conditions in labs, which show that these persons are at a high risk of accidents.
The Food and Drug Administration says that over the years, it has received sporadic reports of motor vehicle accidents caused by motorists driving under the influence of zolpidem. However, in the past, the Food and Drug Administration did not have the depth of data that it needed to actually take action on this matter.
The Indiana personal injury lawyers at Montross Miller Muller Mendelson Kennedy LLP, represent persons injured in automobile accidents across Indiana. If you have been injured in an automobile accident, speak with an experienced lawyer at our firm.