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Over the counter alternatives to ambien. FDA is considering a rule that would require all such products to be accompanied by a box of warnings about potential risks, as well a boxed warning about the risk of overdose. "It really is an uphill battle," says Jeffrey L. Karp, an attorney at Fisher Phillips in New York, who is a member of the FDA's medical device Advisory Committee. "The industry is well aware of this problem and has been taking steps to address it." Ambien's maker, Wyeth, which in 2010 was bought by Pfizer Inc., says in its statement that products provide relief to patients who would otherwise be unable to function without the drug. But company added that it "takes seriously the importance of ensuring safe and effective use of this drug, and we do so in accordance with the requirements of Drug Act and the U.S. Food Drug Administration guidance for the manufacture and prescription of drugs." Patty O'Neill, a spokeswoman for the National Organization on Women, which opposes the FDA regulation, said that while it would not challenge the regulations, she was concerned about the impact that they may have on Ambien. "We are disappointed with the action of FDA," O'Neill said. "We think any rule should not only give people a safer, more accurate warning about the potential side-effects to take Ambien, but should give patients clear information about the risks and benefits of taking it. Ambien provides relief to those who have insomnia and is widely used. If it were not widely used as a sleeping aid, then there would not be as great a concern about the drug causing harm." Ambien, also known by the trade names zolpidem tartrate, zaleplon, zaleplon XR and OCP, is a sedative often prescribed for insomnia, the treatment of anxiety disorders and as an aid in recovering from anesthesia. The FDA estimates that over last five years, Ambien has been prescribed 6.6 million times. "The FDA has been taking significant steps to protect the public from serious side effects of prescribed drugs and is taking action on the latest information," Janet Woodcock, assistant director of the FDA's Center for Drug Evaluation and Research, said in a statement. "The agency will continue to evaluate the risk and benefits of sleep medications. We continue to take action ensure that patients have timely access to safe, effective and proven sleep medicines." In May, FDA Commissioner Martin C. Burch wrote a letter to the heads of American Society Anesthesiologists and the Dental Association voicing concern that the drug is Sibutramine for sale in usa often given to children and adults who might not be able to make responsible choices about its use. The drug can canada drugs united coupon be fatal if swallowed, inhaled or it is injected. According to the FDA, it is not covered by any state insurance program. Ambien is not the only over-the-counter sleep aid that has been linked to serious side effects. According to the FDA, Ambien's label specifies a risk for "severe or unusual cardiovascular effects," including "tremor, chest pain, hypertension, discomfort or difficulty breathing; and in rare cases, sudden death, heart failure or blood clots leading to pulmonary embolism; all for up to seven days after taking the medication without a break of more than 72 hours." The FDA is also considering a new label for zolpidem tartrate, which includes a section in "black box warning" would alert parents that the medication can cause "serious heart and blood problems, including sudden death." In a statement, the FDA said that, "As a result of the evidence gathered in new warning, it is unlikely that Ambien or zolpidem tincture would pose an immediate risk to a child," but acknowledged that the new labeling will be subject to the FDA's approval process.

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