The US Food and Drug Administration (FDA) continued its crackdown on popular sleep drugs, this time asking patients not to consume higher than recommended doses of drugs such as Ambien and Lunesta which could lead of bizarre behaviors, including driving, eating and even having sex while sleeping.
FDA also directed the makers of 13 popular drugs to place strong new warnings on the labels, apart from creating a series of fliers to patients which will explain to them how to safely consume the drugs. Some of the other drugs in question are Butisol Sodium, Carbrital, Dalmane, Doral, Halcion, Placidyl, ProSom, Restoril, Rozerem, Seconal and Sonata.
Dr Russell Katz, director of FDA's neurology division, said that the agency has been receiving a number of letters from patients who have reported the drugs' bizarre side effects. "We don't think that these side effects are sufficiently frequent that it would cause us to re-evaluate whether or not the drugs should be on the market. But we do believe the labeling needs to be changed", he said.
Patients who consume Ambien in particular have reported that they found themselves to be eating or cooking food when they woke up. Some others have reported that they found themselves to be driving a car the previous night, though they don't have any recollection of the drive.
One of the famous cases of the side effects of Ambien has to be the car crash of Rep. Patrick Kennedy, who used to take the drug. So far none of the companies in question have announced that they will be starting new studies to look into the matter.
While admitting that extreme side effects were rare, Dr Carlos Schenck, a senior staff physician at the Minnesota Regional Sleep Disorders Center, said that they were dangerous to the patients in question. "Two of our patients started fires in their kitchen, two drove automobiles...that are serious", he said.
