Physicians soon will be receiving letters from manufacturers of certain prescription sleep aids about new label warnings the FDA has asked those manufacturers to include with the medications.
Many Prescription Sleep Meds To Carry Stronger Warnings
By News Staff
3/20/2007
According to a March 14 news release, recent cases of anaphylaxis, angioedema and complex sleep-related behaviors -- including driving, telephoning or eating while asleep -- have prompted the FDA to request all manufacturers of sedative-hypnotic drugs to add stronger language regarding possible risks to their current product labeling.
Sedative-hypnotic drugs are used to induce or maintain sleep.
The FDA also has requested that manufacturers develop patient medication guides to inform patients about the risks of the medications and precautions that should be taken when using them. These guides should be handed out when the medications are dispensed.
In addition, the FDA is recommending that manufacturers conduct clinical studies to investigate the frequency of complex sleep-related behaviors associated with a given drug.
More information and a list of medications and manufacturers affected by the FDA's new labeling guidelines are available on the FDA Web site.
Sedative-hypnotic drugs are used to induce or maintain sleep.
The FDA also has requested that manufacturers develop patient medication guides to inform patients about the risks of the medications and precautions that should be taken when using them. These guides should be handed out when the medications are dispensed.
In addition, the FDA is recommending that manufacturers conduct clinical studies to investigate the frequency of complex sleep-related behaviors associated with a given drug.
More information and a list of medications and manufacturers affected by the FDA's new labeling guidelines are available on the FDA Web site.
