On January, 10, 2013, the U.S. Food and Drug Administration issued a safety announcement notifying the general public about new information discovered on zolpidem, which is a widely prescribed insomnia drug.
The FDA is now recommending that the bedtime dose be reduced since new data shows that the blood levels in certain patients are high enough the following morning to impair activities that require alertness such as driving. The FDA's focus is on zolpidem products which have been previously approved for bedtime use; these are marketed under the brand names Ambien, Ambien CR, Edluar, Zolpimist, as well as generics.
In addition to shedding light on products containing zolpidem, the FDA is also reminding the public that all drugs that are used to treat insomnia can impair one's ability to drive the following day, and impair other activities that require alertness. The FDA notes that all insomnia drug labels list drowsiness as a common side effect, and they also warn that patients may feel drowsy the day after taking such products. The FDA also states that patients who take insomnia drugs can experience impaired mental alertness the morning after, even if they feel as if they are completely awake.
The safety announcement urged health care professionals to caution all patients that use zolpidem products about the risks involved in next morning impairment, especially for activities requiring mental alertness such as driving. Data showed the greatest risk for next morning impairment to involve the extended-release forms of zolpidem products such as Ambien CR and its generics.
Women are considered to be at a higher risk when taking Ambien due to the fact that their bodies eliminate the zolpidem from their bodies at a slower rate than men. The FDA is now requiring that the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist lower their recommended dose for women. The FDA says the recommended dose for women needs to be lowered from 10 mg down to 5 mg for the immediate- release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for the extended-release products. The FDA is recommending that for men, health care professionals should consider prescribing lower doses which are the same for the women – 5 mg for immediate-release and 6.25 mg for the extended-release products.
The FDA contends that it is continuing to evaluate the risk of impaired mental alertness that is associated with other insomnia drugs including over-the-counter drugs.
Sleeping aids have become increasingly popular over the years as many are available by prescription as are zolpidem products, over-the-counter drugs such as in diphenhydramine HCI products, and more natural products containing melatonin or valerian root, all of which are regulated by the FDA. Unfortunately, many products made for creating deep sleep cause drowsiness and are especially dangerous when they are mixed with alcohol. For years people have been getting in car accidents while on one of these sleep-inducing drugs or even while under the influence of an anti-anxiety medication that also has a sedative effect. If you were injured by a drugged driver, or if you were injured by a
dangerous drug, please waste no time in contacting a
Charleston personal injury attorney from McLeod Law Group, LLC today.