If there is one drug that most people have been desperate enough to consider at one time or another, it is a sleep-aid. 25% of Americans report suffering from occassional sleep problems, while 10% report chronic sleep problems. Sleep deprivation is a problem most of us face at one time or another, and its effect on our lives is inconvenient at best, and life-disrupting at worst.
It is unsurprising then that one of the ways we deal with sleep problems is through the use of prescription sleep aids. In 2010 alone, 66 million prescriptions for sleep aids were written. Popular sleep aids include Ambien, Lunesta, Sonata, Halcion, and Rozerem. For anyone suffering through sleepless nights and the difficult days that follow, these drugs can seem like a lifesaver. But the longer they have been on the market, the more side effects are being reported, and the more their safety is being questioned.
These sleep aids, of which Ambien is the most often prescribed, found themselves the focus of many news stories when reports began surfacing of users engaging in bizarre activities in their sleep. People were getting into their cars and driving in their sleep, sometimes getting arrested. Others would find themselves eating in their sleep, having sex, or even shop-lifting in their sleep.
And it is not only the effects of the drugs during sleep that are worrisome: these drugs also have what is called a “hangover effect,” resulting in impairment in functioning, especially driving, the next day as well. The results can be similar to alcohol impairment.
These reports led to the FDA requiring drug makers to expand their warnings to include the possibility of such hypnotic behaviors.
Did the FDA go far enough to protect the public against these dangers? We don’t think so. The FDA claims that the likelihood of these side effects are not high enough to warrant doing anything more serious, such as pulling the products from the shelves. While the rate of these incidents may be low, their severity is high.
ABC News reported that Professor Rosalind Cartwright took Ambien and awoke in the morning with 4 pelvic fractures, 3 broken ribs, a broken wrist, and a head contusion with bleeding in her brain.
In July of 2012, Kerry Kennedy, ex-wife of Andrew Cuomo, got into a serious accident with a tractor-trailor which was thought to be a result of taking Ambien.
Just this week, news reports surfaced that Ambien likely played a part in an aircraft crash that killed four highly trained Air Force special operators this February in Africa. The pilot entered a nose dive that resulted in the crash, and the cause was “unrecognized spatial disorientation” that was later found to likely be a result of Ambien usage.
With such serious, life-threatening accidents on the line, the FDA is wrong to require nothing more than a warning that most patients will not take into consideration when taking a sleep aid. Even some doctors agree, expressing their concern that patients are inundated with too much prescribing material, none of which affects their actual habits.
But soon the FDA might have to revisit its position on Ambien and other sleep aids, as new studies have reported other disturbing results of their use. The British Medical Journal Open published a study that found an increased risk of cancer and death among those who take prescription sleep aids, even as seldom as 18 times or less a year. In that category of these seldom users, the risk of dying from any cause was 3.5 times higher. In the category of heavy users, defined as 132 or more pills a year, the risk of dying was 5 times higher, in addition to a 35% higher risk of developing cancer. These increased risks may result from the fact that this class of drugs may damage the DNA, and worsen depression.
More bad news: a study of Ambien use in nursing homes found that Ambien use resulted in a 70% increased risk of hip fractures, most of these fractures occurring in otherwise healthy, mobile seniors.
How has the manufacturer of Ambien responded? By dismissing the study outright, claiming it was not done properly, and labeling it “highly questionable”.
But what of the fact that this is not the first study that has revealed an increased risk of death with sleeping pill use? Two other studies, one done in Norway and the other in Canada, both revealed increased risk of death with Ambien.
In keeping with their usual way of dealing with mounting problems, the manufacturers of these drugs will likely continue to dismiss these studies and encourage physicians to prescribe them for a wide-range of patients. Massive direct-to-consumer advertising has resulted in these sleep aids becoming a staple in many medicine cabinets, resulting in huge profits for the pharmaceutical companies.
And to those who find these studies disturbing enough to want to quit taking these pills? Be warned: while you might be anxious to flush your Ambien down the toilet, it is recommended that you wean yourself off the pills gradually. Suddenly stopping the medication can result in rebound insomnia, meaning that you might get little or no sleep for four to ten days. Other withdrawal symptoms may result as well, wuch as extreme emotional distress, muscle cramps, insomnia, nausea and vomitting, and anxiety and confusion. Talk to your doctor about alternatives to sleep aids.
Have your or a loved one suffered as a result of Ambien, Lunesta, Sonata, or any other sleep aid? Call us to discuss.
Sources and Further Reading: