Consumers in the U.S. and Canada are being warned to stay away from popular B.C.-based sleep aid U-Dream after an unapproved substance was discovered.
The product, which markets itself as a natural sleep remedy that combines Eastern medicinal herbs and Western medicine, has been on shelves in both countries for two years, as well as on Amazon and other websites.
But the U.S.-based Food and Drug Administration (FDA) announced this week that a substance similar to the pharmaceutical sleep aid zopiclone, which has not been approved in the U.S., was found in samples of U-Dream.
The FDA said the substance discovered, zopiclone impurity 22, is also similar to eszopiclone, another prescription sedative that is the active ingredient in Lunesta.
While that drug is approved by the FDA, U-Dream is marketed as not containing prescription sleep aids, which the FDA says can cause dizziness and drowsiness the day after it’s taken.
In a statement Friday, Vancouver company Biotrade, which produces U-Dream, said zopiclone is not a regular ingredient and is working to determine how the substance made its way into the product.
Biotrade added that Health Canada also informed the company this week that zopiclone impurity 22 was found in its own tests, after initially raising alarms about an “unidentified material” last month.
Health Canada has not released a statement on the issue and did not respond to requests for comment Friday evening.
The company said Health Canada “has not given any indication regarding the amounts of the impurity in the product, if it poses any risks or whether it is of natural or manufactured origin.”
No confirmed cases of illness or irregular symptoms have been reported, Biotrade said, but it is also recommending people in Canada and the U.S. stop using U-Dream.
“We are committed to doing whatever is required to identify the source of this material and remove it in order to return to stores for the well-being of the many people who benefit from the product,” the company said.
“We are doing further testing and will keep you updated as soon as new information is available.”
More information can be found on U-Dream’s website.
—With files from Paul Johnson