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Page: << Prev | 1 | 2 | 3 | Next >> Last December, the FDA sent letters to the drug makers, asking them to revise their product labels to include warnings about the potential for severe allergic reactions -- called anaphylaxis -- and severe facial swelling -- called angioedema.
At that time, the FDA also asked the manufacturers to add warnings about complex sleep-related behaviors, including sleep-driving, making phone calls, and preparing and eating food or having sex while asleep, Katz said.
In addition to these label changes, the FDA is asking the manufacturers to send letters to health-care providers notifying them about the new warnings. These will start going out this week, according to the FDA.
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The FDA has also asked the drug manufacturers to develop "Patient Medication Guides" to inform people about the risks associated with these drugs and precautions they can take. These guides will be given to patients when one of these drugs is prescribed. There is no deadline for the availability of these guides, Katz said.
Katz said people can minimize their risk of side effects by taking only the prescribed dose and not mixing the drugs with alcohol or other medicines that have similar effects.
Since little is known about these drugs and their potential side effects, the FDA has recommended that the drug makers carry out clinical studies to find out which medications are most associated with sleep-driving and other odd sleep behaviors.
"So far, no drug company has agreed to do these studies," Katz said.
One insomnia expert thinks the labeling changes for these drugs are long overdue, but don't go far enough.
"It's about time," said Gregg Jacobs, an insomnia specialist at the Sleep Disorders Center at Beth Israel Deaconess Medical Center in Boston, and an assistant professor of psychiatry at Harvard Medical School. "It's been demonstrated that pharmaceutical companies exaggerate the benefits of medication and minimize the side effects."
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