Emergency department (ED) visits for adverse reactions related to the sleep drug zolpidem increased by almost 220% in a recent 5-year period, according to the Substance Abuse and Mental Health Services Administration (SAMHSA).
Women and the elderly appear to be most prone to adverse reactions linked to zolpidem, a widely prescribed medication approved by the US Food and Drug Administration (FDA) for short-term treatment of insomnia. Zolpidem is the active ingredient in Ambien, Ambien CR, Edluar, and Zolpimist.
The information was contained in a report from the SAMHSA's Drug Abuse Warning Network (DAWN), a public health surveillance system that monitors drug-related ED visits across the United States.
"It's really important that doctors query their patients about what other medications they're on," said Peter Delany, PhD, director, Center for Behavioral Health Statistics and Quality, SAMHSA. "I don't want to tell doctors not to prescribe this drug, but they should also look at alternative strategies for treating insomnia such as sleep hygiene," which can include avoiding caffeine, exercising regularly, and sleeping in quiet darkened surroundings.
As well, doctors should work with their patients to ensure that all prescribing goes through 1 pharmacy. That way, pharmacists can act as a "second level" to flag potential drug interactions, said Dr. Delany.
According to the report, in 2010 there were 64,175 ED visits involving zolpidem, about 30% of which were attributed to adverse reactions. The number of these visits increased nearly 220%, from 6111 in 2005 to 19,487 in 2010.
Increase Among Women
The increase appeared to have affected women more. Zolpidem-related ED visits involving adverse reactions increased overall by 274% among women and by 144% among men. In 2010, 13,180 zolpidem-related ED visits involved adverse reactions among women, which was more than double that for men (6306).
. Women are more likely to go to their doctor with an insomnia concern, and the physician will probably try to address "this very real physical problem," said Dr. Delany. "So are more prescriptions being written for female patients than for male patients? I think there's a pretty good bet that's probably the case."
Earlier this year, the, FDA responded to increasing reports of adverse reactions by requiring manufacturers of drugs containing zolpidem to halve the recommended dose for women. Zolpidem comes in 5-mg and 10-mg doses, and an extended-release version comes in 6.25-mg and 12.5-mg doses. The FDA also suggested that manufacturers reduce the recommended dose for men.
Research shows that women metabolize the drug differently than men and that 8 hours after taking the drug, a sizable proportion of women still have levels in their system that could be impairing, according to Sam Fleishman MD, president, American Academy of Sleep Medicine, and medical director, Behavioral health and Sleep Medicine, Cape Fear Valley Health, Fayetteville, North Carolina.
Dr. Sam Fleishman
The elderly may also be more sensitive to the sleep drug. In 2010, patients aged 65 years and older represented the largest proportion (32%) of zolpidem-related ED visits involving adverse reactions, followed by patients aged 45 to 54 years (22%).
As with women, the FDA has recommended that the dose of most drugs containing zolpidem be reduced by half when prescribed for the elderly. However, studies show that the older population are often being prescribed the higher dose, which may increase adverse reactions.
According to the report, about 40% of the ED visits involved zolpidem alone and half involved other pharmaceuticals combined with zolpidem. Narcotic pain relievers were the most common type of pharmaceutical combined with zolpidem (21%), followed by other antianxiety and insomnia medications (16%).
Adverse Reactions
Adverse reactions related to zolpidem can include daytime drowsiness, dizziness, hallucinations, behavioral changes (eg, bizarre behavior and agitation), and complex behaviors, such as sleepwalking and "sleep driving." When zolpidem is combined with drugs that depress the central nervous system, such as antianxiety medications (eg, benzodiazepines), narcotic pain relievers, and alcohol, the sedative effects of zolpidem can be dangerously enhanced, said the report.
The report stresses that zolpidem should be used safely and for only a short period of time. "It's important for physicians to educate and re-educate their patients on how they should use these medications, how often they should use them, and when they should take them before going to bed, and that needs to be an on-going discussion," said Dr. Fleishman.
Medications with zolpidem can be "useful tools," but they need to be used with care, added Dr. Fleishman. "We all need to take a step back, be more thoughtful and look for ways to reduce the dose and limit how often people use these drugs."
SAMHSA is involved in several initiatives to promote prevention and risk reduction for prescription drug related problems. For example, its Strategic Prevention Framework - Partnerships for Success II (SPF-PFS II) grant program provides funding to communities for programs raising awareness about the problems of prescription drug misuse and abuse among young people aged 12 to 25.
SAMHSA has also partnered with the National Council on Patient Information and Education on the "Not Worth the Risk — Even If It's Legal" campaign. The partnership has developed and distributed educational and outreach messages to encourage parents to communicate with their teens on prescription drug abuse and misuse.
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