Health Canada recalls U-Dream sleep aid because of "serious health risks"

Health Canada is advising Canadians that it has tested several U-Dream Lite and U-Dream Full Night herbal sleep-aid products and has found that they contain a substance similar to the prescription drug zopiclone, which may pose serious health risks.

“Zopiclone is used to treat insomnia,” said Health Canada in a statement. “Side effects include drowsiness, dizziness, memory loss, hallucinations, and abnormal sleep behaviours while not fully awake including sleep driving (which can result in serious injuries).”

Zopiclone use “may lead to dependence or abuse, and stopping the drug abruptly may cause withdrawal symptoms, including convulsions, tremor, muscle cramps, vomiting, sweating, hallucinations and difficulty sleeping,” the agency added. “In addition, zopiclone should not be used by pregnant or nursing women, children, or patients with breathing difficulties.

Health Canada tested the products after receiving complaints of unusual side effects — such as symptoms of withdrawal and dependence — suggesting that the products may contain a substance not listed on the product label.

It has also suspended all of the company’s U-Dream and U-Dreams product licences, “which means it is now illegal for any person or company to sell these products in Canada.”

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The company, Biotrade Canada Ltd., has indicated that U-Dream Lite (under NPNs 80070773, 80072688 and 80088075) and U-Dream Full Night (under NPNs 80070691, 80072690 and 80088078) are the only products it has been marketing in Canada. Health Canada has asked Biotrade Canada Ltd. to recall the products and “will take further action as needed.”

Who is affected

Consumers who have bought or are using these products:

Health Canada