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(Medical-NewsWire.com, January 17, 2013 ) San Francisco, CA -- Due to heightened risk of dangerous driving practices, United States Federal Drug Administration has urged doctors and patients to practice lower bedtime doses for insomnia.
The newest safety warnings are are pointed toward those who use the sleep drug zopidem, which is sold as a generic under brand names such as Ambien, Ambien CR, Edluar, and Zolpimist.
The newly issued warnings follow clinical tests that lead to the approval for the drug were coupled with testing involving driving simulators. The FDA will require driving-simulation tests to be conducted on any new compound or medication that applies to combating insomnia.
IMS Health, which is a healthcare technology and information company out of Plymouth Meeting, stated that 60 million prescriptions were written in 2011 to help combat sleeping issues in patience. Two-thirds of whom were prescribed zolpidem.
A director within the FDA’s Center for Drug Evaluation and Research, urged patients to take the time to discuss the use of such medication with doctors, and should do so when choosing to switch medication regimes as well.
“We hope less of the drug will be in the bloodstream in the morning driving hours,” Unger said in a conference call with reporters.
Before the onset of generic medication competition, the two version of Ambien and its maker, Sanofi-Aventis, held a rather strong hold of the market.
Now all the sleeping pills hold zolpidem in them, but each of the FDA-Approved drugs have labels which warn of similar symptoms akin to drowsiness. The agency stated that the extended-release forms of the drug zolpidem showed that the highest risk for next-morning effects. The agency also noted that women seemed to be at higher risk than men when it came to susceptibility to the side effects, due to the drug staying in the system longer.
Usher stated that the agency was not influenced by celebrity-related accidents involving Ambien or zolpidem.
The new information was not tied to any specific case,” Usher said, without naming names. But he added, in reference to reports of celebrity accidents, “We don’t know the time of the accidents, we don’t know the last dosage, or whether there was alcohol or other drugs involved.”
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