Sleeping pills pose added death risk for obese patients

The mortality rate for obese patients who regularly take sleeping pills is nine times higher than the death risk for similar patients who do not use the drugs, said a study presented at an American Heart Assn. scientific meeting in March.

Researchers examined the medical records of more than 34,000 patients treated in the Geisinger Health System in Pennsylvania. After controlling for sex, age, smoking status, alcohol use, marital status and ethnicity, the obese patients who took hypnotic medicines regularly — at least 132 pills annually — were 9.3 times likelier to die than patients with similar health who did not. Even obese patients who took 18 pills or fewer annually had a death rate eight times higher.

The added risk of sleeping pills for obese patients also applied to drugs such as zolpidem, marketed as Ambien by Sanofi-Aventis, which is thought to be less problematic than older, longer-acting sedatives. Obese patients using zolpidem regularly had an eightfold higher death risk, researchers reported. Between 6% and 10% of U.S. adults took a sleeping pill in 2010.

There are a number of ways in which sleeping pills can raise the death risk in obese patients, said Robert Langer, MD, MPH, who conducted the research with two physicians affiliated with Scripps Clinic Viterbi Family Sleep Center in La Jolla, Calif.

“Among the obese, perhaps the most important mechanism is sleep apnea, which is also associated with increases in cardiovascular deaths and in strokes, heart attacks and related kinds of vascular events,” said Dr. Langer, a family physician, epidemiologist and preventive medicine specialist. “It’s also quite possible that in the obese there’s a disturbance of the brain stem stimulation to breathe and that these drugs may preferentially dull some of that stimulation and cause people to have respiratory failure at night. That is especially associated with obesity.”

Obese men who take sleeping pills have double the death risk of obese women, Dr. Langer and his colleagues reported. The findings are a follow-up to research published Feb. 27 in the peer-reviewed, open-access journal BMJ Open. Among all patients — not just the obese — those taking sleeping pills had a death rate at least 3.6 times higher than patients who did not, said the study (link).

Sanofi-Aventis, maker of Ambien, did not respond to a request for comment by this article’s deadline. In response to the BMJ Open study, however, the company released a statement saying, “Ambien has more than 17 years of real-world experience and is safe and effective when prescribed and taken according to its labeling. ... Ambien should be prescribed in strict adherence to its labeling, and patients should take their medication as prescribed.” The Ambien label does not specifically warn against using it in obese patients.

Implications for practice

Eighteen previous studies have found an elevated mortality risk associated with sleeping pills, said Dr. Langer, medical director of the Jackson Hole Center for Preventive Medicine in Jackson, Wyo. He noted that more research is needed to determine how sleeping pills may be harming patients, but in the meantime he advised physicians to scrutinize their prescribing of these medications.

“These results should make physicians considerably more cautious about the extent to which they recommend these drugs,” he said. “We are not saying that these drugs have no role at all, but we are saying they’ve probably become overused. For short-term use, especially for people who have some major need to be able to get to sleep because of travel, odd work shifts or things like that, they may have a place. But most people who use them have gotten to the point where they’ve used them regularly, and the hazard is well beyond what’s appropriate.”

Dr. Langer said physicians should consider other options to treat insomnia, such as the supplement melatonin, light therapy, sleep-hygiene counseling and cognitive behavioral therapy.