The U.S. Food and Drug Administration has told the manufacturers of 13 brands of sleeping pills, including Ambien, Lunesta and Rozerem, to change labels on the pills to warn consumers of possible adverse events such as severe allergic reactions, “sleep-driving” and preparing and eating food while asleep.
The FDA defined sleep driving as “driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.”
Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, said Wednesday the agency first alerted manufacturers about the stronger labeling in December and has spent the past three months working with the drug companies on the wording, and preparing to notify doctors and consumers of the risks.
“There are a number of prescription sleep aids available that are well-tolerated and effective for many people,” Galson said. “However, after reviewing the available post-marketing adverse event information for these products, the FDA concluded that labeling changes are necessary.”
Dr. Glenn Singer, director of the Sleep Disorders Center at Broward General Medical Center, said the FDA lumped together the older class of sleeping pills with the newer ones, such as Ambien and Lunesta, which seemed to have a safer profile.
“We knew the older drugs were more dangerous, especially in the elderly,” Singer said. “We would see things like hip fractures because people would get up in the night and fall.”
“The use of these medications is often done without people doing a good evaluation to get to the bottom of the problem,” Singer said. “No death certificate is ever signed `insomnia,’ and there are some very good behavioral techniques to try [before opting for sleeping pills],” he said.
“The use of these pills has soared over the past few years,” said Neal Nay, manager of JFK Medical Center’s Sleep Disorders Center in Atlantis. “What we propose instead is cognitive behavioral therapy. A study came out about a year ago that showed that if you stick to it for two to three weeks, it works, but it takes some self-discipline,” Nay said.
The FDA also asked each product manufacturer to send letters to health care providers to notify them about the new warnings. The manufacturers will begin sending the letters this week.
The agency also asked the drug companies to create patient medication guides about proper use and the recommendation to avoid drinking alcohol or taking other central nervous system depressants while using the sleeping pills.
And, the FDA recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep driving and other complex behaviors occur in association with individual drug products.
The drugs on the list are: Ambien, Butisol sodium, Carbrital, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconal and Sonata.