As the nation increasingly relies on sleeping pills, new information last week suggests they may not be as safe as thought.
Drugs like Ambien, Lunesta and Sonata, older drugs like Valium and barbiturates and even sedative antihistamines all correlate with a three-fold increase in the hazard of death say researchers in last week’s British Medical Journal (BMJ). Some of the mortality stemmed from a “significant elevation of incident cancer,” say the researchers and subjects did not have pre-existing disease.
Sleeping pills have never been Big Pharma’s finest hour. In the 1960s, barbiturates were immortalized by Marilyn Monroe’s death and by the 1967 movie Valley of the Dolls, which starred Sharon Tate, soon before her grisly murder. In 1993, the sleeping pill Halcion was banned in the United Kingdom and other countries for causing amnesia, paranoia, depression, hallucinations, and violence in users. Travelers, among its biggest users, would find themselves on the other side of the Atlantic Ocean and not remember boarding a plane. And in 2001, a similar pill, Dalmane, was said to “increase the risk of an injurious accident more than five times normal,” at FDA/National Transportation Safety Board hearings.
And there were more transportation risks. Who can forget former Rhode Island Representative Patrick Kennedy driving to Capitol Hill to “vote” at 2:45 a.m. on Ambien and other drugs and crashing his car in 2006? Law enforcement officials reported that traffic accidents increased when Ambien became popular with some drivers not even recognizing the police officers there to arrest them. (Hey Dude—help me get my car out of this ditch!) The FDA soon issued warnings about such apparent sleeping pill blackouts—the potential of “complex sleep-related behaviors” that may include “sleep-driving, making phone calls and preparing and eating food [while asleep]”—for Ambien and twelve other sleeping pills.
Sanofi-Aventis, Ambien’s manufacturer, was forced to publish ads telling people if they were going to take Ambien, to get in bed and stay there. (Or you’ll break out in handcuffs.)
Of 4,336 people on Ambien in the BMJ study, there were 265 deaths compared with 295 deaths among 23,671 people not on Ambien.
Even though sleeping pills like Ambien, Lunesta, Sonata and Rozerem only decrease get-to-sleep time by 18 minutes, according to a major government study, they have been a gold mine for Big Pharma since direct-to-consumer (DTC) advertising, since everyone sleeps—or watches TV when they can’t. In FDA documents, Rozerem, worked no better than a placebo, but its sales shot up 60 percent thanks to DTC advertising, reported the New York Times.
To “grow” the insomnia market, Pharma has rolled out subcategories as it did with different kinds depression. You could have chronic, acute, transient, initial or delayed- onset insomnia. You could also have middle-of-the-night, early-morning or menopausal insomnia—or even non-restful sleep. But if further research confirms the BMJ findings, enduring the minutes before you fall asleep may be better for your heath than popping a pill. You can always watch the TV commercials for sleeping pills.
Martha Rosenberg’s first book, “Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health,” will be published by Prometheus Books in 2012.