According to new data from the Scripps Clinic Sleep Center in San Diego, people taking medication for insomnia now have something else to lose sleep over.
Research published yesterday in the medical journal BMJ by Daniel F. Kripke, Robert D. Langer and Lawrence E. Kline points to very strong links between sleeping pills and early death. This was a large study with clear, compelling and statistically significant findings. The results were pretty surprising, said Kripke in an interview with Time. And as far as I know, the mortality and cancer risks are not reflected in any [sleep aid medication] labels.
The study followed 10,529 people who took sleeping pills, as well as about 23,676 others who did not, for about 2.5 years between 2002 and 2007. The subjects' average age was 54.
Even those who took less than 18 pills a year faced increased mortality--they were 3.6 times more likely to die than non-users. Those who took between 18 and 132 doses a year were four times more likely, and those who took 132 or more were five times more likely.
These are frightening statistics for the 6 to 10 percent of Americans who use sleeping aids, but study authors note that the overall number of deaths observed was still small. Furthermore, the research has only proven correlation, not causation. Just because sleeping aids are linked to fatalities doesn't mean they are necessarily to blame.
On the other hand, Kripke insists that the experiment accounted for variables very thoroughly. Causation has not been scientifically proven, but it looks likely.
So how exactly might these medications increase the likelihood of death? As it turns out, the mortality connection is a broad one; possible risks associated with hypnotic medication run the gamut. Sleeping aids can worsen sleep apnea, for instance, which leads to problems with hypertension and cardiovascular disease. They can also impair motor skills, causing injuries and car accidents. Benzodiazepines like ProSom were often present in mixed-drug overdose fatalities. Then there's the carcinogen concern: high doses of hypnotics led to a whopping 35 percent increase in cancer diagnoses. Temazepam, which is sold under the brand name Restoril, had the strongest cancer link. All hypnotics can worsen depression and the associated risk of suicide. The study even linked hypnotic drugs with sleep eating, which increases the likelihood of poor diet and obesity.
Those consumers who are wondering whether their particular prescription is dangerous are in for some bad news. The term 'hypnotic' encompasses a wide range of sleeping aids: benzodiazepines like ProSom and Restoril, non-benzodiazepines like Ambien, Lunesta and Sonata, and even barbiturates like Butisol and Nembutal.
Since causality has not been proven, there's no word yet on whether manufacturers of these medications will be required to change their labels. Representatives of Sanofi and Covidien, pharmaceutical companies that produce Ambiem and Restoril respectively, could not be reached for comment. A medical associate from Sunovion, which produces Lunesta, said via email that LUNESTA® (eszopiclone) is safe and effective as demonstrated in clinical trials that served as the basis for approval by the U.S. Food and Drug Administration (FDA) and has helped millions of patients manage their insomnia, adding that after extensive clinical trials, the medication's effect on mortality was no different than that of placebos.