Popular Meds May Lead to Sleepwalking, Sleep-Driving
Sleeping pills may give you more than a good night’s rest. According to the Food and Drug Administration, the medications increase your chances of falling asleep behind the wheel and ending up in a serious or fatal auto accident.
Four years after a major study concluded that certain sleep meds may double your chances of falling asleep while driving, the agency said that it would begin requiring the manufacturers to include stronger warnings on their labels.
Agency Targets Sleep Medications
The FDA focused on Ambien, Lunesta, Sonata, and three generic forms of Ambien that go by its chemical name of Zolpidem. The drug makers will have to list possible side effects such as sleepwalking and sleep driving, both of which involve taking risks without being fully awake.
The printed warnings, highlighted in boxed text, are the most prominent kind of warning that the agency requires.
Although rare, sleepwalking and sleep driving can lead to injuries or deadly accidents. The agency is advising doctors to avoid prescribing sleeping medicine to people who have already experienced such side effects. It is also advising users to stop taking the meds and contact their health-care providers immediately if they experience “a complex sleep behavior where you engage in activities while you are not fully awake…or if you do not remember activities you have done while taking the medicine.”
In a 2018 advisory, the FDA alerted the public that Ambien and its generic forms can cause dangerous drowsiness even after a good night’s sleep.
In one case, a Georgia woman was arrested for driving while intoxicated after she was observed going in the wrong direction. The diagnosis was mistaken; a blood test conducted on the day of her arrest found no alcohol or drugs in her system besides the prescribed medication. But the test did find Zolpidem. According to her report, she had taken the prescribed dosage and slept for more than eight hours. Nevertheless, she blacked out while on the road.
In another case, an evaluation of a Colorado truck driver charged in a fatal crash in South Dakota determined that his central nervous system had been impaired by a depressant. He acknowledged having used Ambien two days before the accident.
20 Million Prescriptions
Prescriptions for sleeping aids grew from an estimated 5.3 million in 1999 to more than 20 million in 2010. About 12.5 percent of people reporting sleeping difficulties are using the medications.
Users have been reporting strange half-waking experiences for some time, leading the FDA to issue a milder warning about side effects in 2007. Most of the reports were about rare incidents involving Ambien and other zolpidem medications. Such incidents may be more common than is reported, however. People do not always remember sleepwalking to the kitchen and would even less often make the connection to sleeping pills.
The potential side effects are not news to health care professionals specializing in sleep problems like Dr. Ilene Rosen, professor at the University of Pennsylvania Medical School and former president of the American Academy of Sleep Medicine.
“This is something I’ve been telling my patients for the last 15 years,” she told The New York Times in 2013. “And I’d like to think we’ve done a good job putting the news out there, that these drugs have some risks.”
Drowsy Driving and Auto Accidents
The U.S. Centers for Disease Control and Prevention estimates that 1 in 25 adult drivers have fallen asleep at the wheel at some point during the previous month. One cause is “medications that make [drivers] sleepy.”
According to the National Highway Traffic Safety Administration, “Between 2005 and 2009, there was an estimated average of 83,000 crashes each year related to drowsy driving. This annual average includes almost 886 fatal crashes (2.5% of all fatal crashes), an estimated 37,000 injury crashes, and an estimated 45,000 property damage only crashes.”
In explaining its 2019 ruling, the FDA noted that it has reviewed “66 cases of complex sleep behaviors occurring with these medicines over the past 26 years that resulted in serious injuries, including death.”
These cases included accidental overdoses, falls, burns, near drowning, exposure to extreme cold temperatures leading to loss of limb, carbon monoxide poisoning, drowning, hypothermia, motor vehicle collisions with the patient driving, and self-injuries such as gunshot wounds and apparent suicide attempts. Patients usually did not remember these events…
FDA is also reminding the public that all medicines taken for insomnia can impair driving and activities that require alertness the morning after use.
If you or a loved one has been injured in an auto accident in Colorado that may be due to drowsy driving, contact Dan Rosen at (303) 454-8000 or (800) ROSEN-911 for a free consultation to discuss the details of your case.