Patients taking prescription sleeping pills, even if they received only a short-term supply, have a more than 3 times greater risk of dying over a few years than a matched group of patients not taking these medications, according to a study published in BMJ Open.
Between 6% and 10% of US individuals take hypnotic medications to help them sleep, despite evidence from at least 2 dozen studies suggesting such use may have serious risks. Many of the studies have had limitations, such as a small size or design issues, that make it difficult to gauge whether the drug is causing these deaths or to quantify how great the risks are. A randomized clinical trial could provide more definitive evidence, but the evidence of an elevated risk associated with the drugs raises ethical concerns, making it unlikely that such a trial will be carried out.
To provide stronger data, the researchers from the Scripps Clinic Vierbi Family Sleep Center in La Jolla, Calif, and the Jackson Hole Center for Preventive Medicine in Jackson, Wyo, used a large sample of electronic medical records to identify more than 10 000 patients using hypnotic drugs as sleep aids and compared these individuals with a set of nearly 24 000 patients with similar characteristics who were not taking these pills. They found that the risk of death was 3.6 times greater among patients who had been prescribed between 1 and 18 hypnotic pills in any given year compared with those patients who were not prescribed such drugs; over an average time period of 2.5 years, the risk of death was 4.43 times greater among those prescribed 18 to 132 pills and 5.32% greater among those prescribed more than 132 doses, compared with nonusers. Overall, the percentage of nonusers who died during the observation period was 1.2% compared with 6.1% of the sleeping pill users.
The study also found that the risk of cancer was 35% greater among patients taking higher doses of these medications, but further research is needed to explore this association.
Given these elevated risks, and a growing consensus that behavioral therapies may be more helpful than pharmaceutical treatment, the authors urge physicians to reconsider using these drugs even in the short-term.
“The meager benefits of hypnotics, as critically reviewed by groups without financial interest, would not justify substantial risks,” the authors conclude.