Consumers who usecertain sleeping aidsmay be susceptible to adverse reactions, including sleep driving and severe swelling, the U.S. Food and Drug Administration said Wednesday.
The federal watchdog has asked drug manufacturers to use stronger language in describing the risks of using 13 sedative-hypnotic products, six of which are sold in Canada.
"There are a number of prescription sleep aids available that are well tolerated and effective for many people," said Steven Galson, director of FDA's Center for Drug Evaluation and Research, in a release.
"However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labelling changes are necessary to inform health-care providers and consumers about risks."
The new packaging rules apply to:
- Ambien/Ambien CR. (approved but not marketed in Canada).
- Butisol Sodium.
- Dalmane (available in Canada under the same name).
- Halcion (available in Canada under the same name).
- Lunesta (available in Canada as Imovane).
- Placidyl (available in Canada under the same name).
- Restoril (available in Canada under the same name).
- Sonata (available in Canada as Starnoc).
Manufacturers must nowinclude warnings on the packaging advising consumers of potential risks, which include complex sleep behaviours. The FDA said thedrugs' side-effects may include causing people to drive, make phone calls,or prepare and eat food while not fully awake. The patients have no memory of the activities.
The drug companies have also been asked to write letters to doctors, advising them of the side-effects. They must also produce brochures that advise patients of the potential risks.
Health Canada has not put out any warnings about the products.
The department's experts arereviewing the product monographs of sleep drugs marketed in Canada to determine if any changes are needed, said Health Canada spokesman Alastair Sinclair.
New information will be made public to Canadians and Canadian health-care professionals as soon as it is available, Sinclair added.