The current recommended doses for Ambien, Ambien CR, Edluar and Zolpimist -- widely used sleep drugs that contain the active ingredient zolpidem -- are being scrapped.
The U.S. Food and Drug Administration says it will require the makers of those sleep aids to lower the recommended doses because 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.
Less residual effect
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.
Typical is the case of Darcydola of Prior Lake, MN, who wrote that after taking one 10 mg pill of Ambien, she woke up in her kitchen. "I had made a disaster of the kitchen looking for food," she said in a ConsumerAffairs post. "I spoke on the phone to my boyfriend and was sobbing apparently. I also sent him strange emails. I have no memory of any of this. This medication should be taken off the market."
A bit more extreme is the experience of L. of Waldorf, MD. "I made phone calls to a woman and told her that her husband had an affair," she told ConsumerAffairs."I beat up on my husband, drove and hit a pole. I have no memory of any of this. My husband told me what happened. I somehow took 17 pills in 3 days! It's a wonder I am not dead. I have to pick up the pieces to my life now. I am reading the internet about this drug, I don't know how it remains on the market. If legal troubles are the result of this, I just might sue!"
Lowering the dose
The FDA has informed the manufacturers that the recommended dosage of zolpidem for women should be lowered from 10 milligrams (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 healthcare 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. (Both Ambien and Ambien CR are also available as generics)
“To decrease the potential risk of impairment with all insomnia drugs, healthcare professionals should prescribe, and patients should take, the lowest dose capable of treating the patient’s insomnia,” said Ellis Unger, M.D., 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.”
Changes are study-driven
The labeling change is based on findings in driving simulation and laboratory studies showing that, in some individuals, zolpidem blood levels the morning after use appear capable of impairing driving to a degree that increases the risk of a motor vehicle accident.
“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 Dr. Unger. “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.”
Morning impairment is common
The FDA also reminded the public that morning impairment is not limited to zolpidem. Drowsiness is listed as a common side effect in the labels of all insomnia drugs, along with warnings that people may still feel drowsy the next day after taking one of these products. Moreover alertness can be impaired even in people who do not feel drowsy.
People who are currently taking the higher doses (10 mg or 12.5 mg) of zolpidem-containing insomnia medicines should continue taking the prescribed dose as directed until discussing with their health care professional how to safely continue to take the medicine. Patients should read the Medication Guide that comes along with their medication for additional information on the benefits and risks of these products.
The FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (nonprescription) drugs.