It's estimated that as many as 10 percent of Americans occasionally rely on prescription sleep medication for a good night’s rest. But newly discovered risks associated with the use of these drugs could cause some people to lose sleep. A recent study published in the British journal BMJ Open found that adults who were prescribed eight common sleep drugs, including Ambien and Restoril, were up to five times more likely to die than non-users. But the study's results and methodology have been challenged by sleeping-pill manufacturers, as well as many doctors and patients.
Using electronic records from Pennsylvania's Geisinger Health System, researchers compared the mortality rates of about 10,500 adults who had been prescribed sleeping pills with a similar group of about 23,600 adults who weren’t prescribed the drugs. The average age of the patients was 54. Over two-and-a-half years, 6 percent of those who had been prescribed sleeping pills died, compared with 1 percent of non-users. And the more doses people were prescribed, the higher their risk: Patients prescribed less than 18 doses a year were 3.5 times more likely to die than those without a prescription, but those prescribed more than 132 doses faced a five-fold increase. (The researchers based their study on data about sleeping pill prescriptions, not consumption.) The co-authors estimated that the sleep drugs may be a contributing factor in as many as 507,000 deaths in the United States each year.
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Even after the researchers adjusted their data to factor in the expected mortality rates of patients who had coronary heart disease, hypertension, diabetes and other conditions, the correlation between the sleeping pills and increased mortality remained: Among people in the study who had the same conditions, more sleeping pill users died than non-users. "We tried every practical strategy to make these associations go away, thinking that they could be due to use by people with more health problems," says Dr. Robert Langer of the Jackson Hole Center for Preventive Medicine in Jackson, Wyo., a co-author of the study. "But no matter what we did, the associations with higher mortality held."
Is There a Connection Between Sleeping Pills and Mortality?
Critics of the study, however, say that it was not a randomized, controlled trial of the kind that could more clearly establish cause-and-effect between the drugs and mortality rates. Co-author Dr. Lawrence Kline, medical director of the Scripps Clinic’s Viterbi Family Sleep Center in La Jolla, Calif., acknowledges the concerns. "Our results are based on observational data," he says, "so even though we did everything we could to ensure their validity, it's still possible that other factors explain the associations.”
The researchers did not collect information on the mental health of the patients whose data they tracked, and also did not have access to information on why doctors prescribed sleeping pills to the patients, or the specific causes of their deaths. Several experts commenting on the study have pointed out that patients who suffered from insomnia would generally also have been vulnerable to other health risks that could lead to premature death, and that, as a population, sleeping pill users tended to be less healthy. Multiple studies have linked insomnia to poor health outcomes including mental illness, cardiac disease and hip fractures in the elderly, says Dr. Daniel Buysse, director of the Neuroscience Clinical and Translational Research Center at the University of Pittsburgh School of Medicine.
"Depression, in particular, could account for some of the increased death rate," says Dr. Shelby Harris, director of the Behavioral Sleep Medicine Program at Montefiore Medical Center in New York City. "The mix of insomnia, depression and other unknown medical illnesses may increase the death rate.”
The study's authors did speculate that sleeping pill use, which can impair cognitive and motor skills, could have led to more car crashes and similar accidents among the patients; that patients who took the pills because they suffered from sleep apnea would have been more likely to have had heart problems; and that insomniacs may have had higher rates of night-time eating, incurring the health risks of obesity.
Other Means of Treating Insomnia
Before turning to sleeping pills, many sleep specialists recommend that people with insomnia first try cognitive behavioral therapy, in which therapists help patients develop better sleep habits, like sleeping in a cool, dark room and avoiding caffeine. Buysse says insomnia can sometimes be treated with just two sessions of therapy, although the treatment isn’t always practical in cases of acute insomnia triggered by illness or extreme stress, like a loved one’s death. Experts also stress the importance of treating underlying psychological or emotional conditions that may be impairing sleep.
It's also important that people follow proper guidelines when taking sleeping pills. "It is often not the medicine itself, but patient misuse of it that causes the greatest issues," says clinical psychologist Michael Breus, a fellow of the American Academy of Sleep Medicine. People taking sleeping pills should avoid alcohol, follow a regular sleep schedule, and allow enough time for a full night’s sleep after taking the pills, he advises.
If you take sleeping pills and are concerned about the study's results, most sleep-care professionals advise that you not stop taking the medications immediately, but instead consult with your doctors, in part because quitting the pills generally requires a tapering-off period of several weeks to avoid symptoms of withdrawal.
Doctors wrote 60 million prescriptions for sleeping pills in the United States in 2010, and despite the concerns raised by the new study, the drugs will remain a primary treatment option for people living with insomnia and other sleep disruptions. "The results do raise cause for concern," Harris says, "but I wouldn't make any major changes in treatment protocols until more data comes out. We need more replications of the data.”
Until such results appear, many doctors will remain skeptical about the magnitude of risk found in the study, says Buysse, who sees as especially problematic the finding that fewer than 18 doses a year raised one's odds of dying nearly four-fold. "These drugs aren’t risk-free," he says, "but they’ve been around for decades and it is not plausible that such a huge risk would go undetected given the millions of doses worldwide."