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[News] FDA Requiring Lower Dose for Insomnia Meds
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FDA Requiring Lower Dose for Insomnia Meds
FDA Requiring Lower Recommended Dose for Insomnia Meds

The US Food and Drug Administration is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses.

New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours.

Since women eliminate zolpidem from their bodies more slowly than men, the FDA has notified the manufacturers that the recommended dose should be lowered for women and that the labeling should recommend that health care professionals consider a lower dose for men.

Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs. The FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.

The FDA has informed the manufacturers that the recommended dosage of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).

For men, the FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses (5 mg for immediate-release products and 6.25 mg for extended-release products). These products are currently available on the market in both the higher and lower dosages.

"To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient's insomnia," said Ellis Unger, MD, director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research. "Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate."


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02-27-2013 09:11 AM
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Shastzi Offline

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Post: #2
RE: FDA Requiring Lower Dose for Insomnia Meds
Maybe you just need some "Puppy Uppers"?

=O.O=

"With ordinary talent and extraordinary perseverance, all things are attainable." - Thomas Foxwell Buxton

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02-27-2013 09:15 AM
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zimlich Offline

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Post: #3
RE: FDA Requiring Lower Dose for Insomnia Meds
That's quite a drop in the dosage. I wonder if there were accidents associated with it's use.
Remember when people were taking halcion and killing their spouse in the middle of the night and pleading "not guity" because they were under the influence of the drug.
From 1993-

PONTIAC, MICH. — A man who said the sleeping pill Halcion drove him to shoot his wife to death was found innocent by reason of insanity. John Caulley admitted donning a mask and ambushing his estranged wife, Kathleen, outside their Troy home in 1988. The 44-year-old former stockbroker had started taking the prescription drug three months earlier. Critics have said Halcion can cause serious side effects, including short-term memory loss, violent behavior and hallucinations. The federal Food and Drug Administration concluded in 1992 it was safe and effective when used as directed. Caulley was convicted of first-degree murder in 1990. But an appeals court ordered a new trial, saying the jury should have been instructed to consider the effects of Halcion.
02-27-2013 10:28 AM
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Shastzi Offline

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Post: #4
RE: FDA Requiring Lower Dose for Insomnia Meds
"NSAIDs such as ibuprofen, naproxen, Voltaren, Celebrex and others provide relief for those who suffer from painful arthritis, lupus or other debilitating conditions. But when these patients also have heart trouble, the drugs' use is cause for concern."

I was on Celebrex when it first was approved for OTC sales.
It worked great for joint pain...but it also sent me to the ER with atrial fibrilation. (No previous heart issues!! )

My point is, FDA will APPROVE lots of things that are still bad for you.

"With ordinary talent and extraordinary perseverance, all things are attainable." - Thomas Foxwell Buxton

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02-27-2013 01:59 PM
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