The FDA has announced the manufacturers of certain sleep drugs must lower the current recommended doses. The federal agency said that in the morning patients may be "high enough" to impair daily activities in the morning that require alertness.
In a Jan. 10, 2013 announcement the U.S. Food and Drug Administration (FDA) said that the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, makers of commonly used sleep drugs, must lower their recommended bedtime doses.
Ambien and Ambien CR are also sold as generic drugs.
The reason for the new requirement is that the agency says that new data shows that some patients had elevated levels of zolpidem, the active ingredient in these drugs, in their blood levels in the morning. Users who need to drive or do other activities that require a person to be alert could still be "high enough" to be impaired, said the FDA.
“Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people’s mental alertness and ability to drive,” said said Dr. Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation, in the press release. “Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment.”
Lower doses would mean less of the sleep drug would be in the user's blood upon waking in the morning. The agency also said that women eliminate zolpidem more slowly than men, so their recommended dose should be lower and the labeling on the drug should recommend healthcare professionals consider lower doses for men as well. Additionally, all users should be cautioned against potential impairment in the morning.
Forbes had linked to a previous report that told of the dangerous side effects related to Ambien and shared stories of some real life risky situations that occurred to users while taking this medication.
Dr. Robert Temple, deputy director for clinical science in the FDA's Center for Drug Evaluation and Research, said that 10 to 15 percent of women will still have levels of zolpidem in their blood eight hours after taking the drug in comparison to about 3 percent of men, according to the New York Times.
The new recommended dosages for women are 5 milligrams (previously at 10 mg) for immediate-release sleep aid drugs and extended release drugs should be lowered from 12.5 milligrams to 6.25 milligrams.
For full details and additional information, please see the FDA's press release.