Health Canada warns Canadians about U-Dream herbal sleep-aid products after tests detect a substance similar to a prescription insomnia drug, which may pose serious health risks
- Starting date:
- December 23, 2019
- Type of communication:
- Advisory
- Subcategory:
- Natural health products
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information, Undeclared Substance
- Audience:
- General Public
- Identification number:
- RA-71951
Last updated: 2019-12-23
OTTAWA – 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. 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). Zopicline 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. 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.
The Department has 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. 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.
Affected products
Health Canada has suspended the following product licences held by Biotrade Canada Ltd.:
| Product | Suspended Natural Product Number (NPN) |
|---|---|
| U-Dream - Full-Night Formula | 80053231 |
| U-Dream - Half-Night Formula | 80053230 |
| U-Dream Full Night |
80070691 80072690 |
| U-Dream Full 350mg |
80088081 80093798 |
| U-Dream Full Night 450mg | 80088078 |
| U-Dream Lite |
80070208 80070773 80072688 |
| U-Dream Lite 350mg |
80088077 80093797 |
| U-Dream Lite 450mg | 80088075 |
|
U-Dream Lite; U-Dream Half Night |
80068852 |
| U-Dreams | 80040083 |
| U-Dreams Full |
80068849 80070204 80070345 |
| U-Dreams Lite | 80070506 |
What consumers should do
- Consult your healthcare practitioner immediately, before stopping use, if you are currently taking this product or if you have been taking it recently. Stopping it suddenly may cause symptoms of withdrawal.
- You should not drive, operate heavy machinery or perform other activities requiring mental alertness until you have safely stopped taking this product.
- Consult your healthcare professional if you have used any of these products and have health concerns.
- Report any health product-related adverse reactions or complaints to Health Canada.
Who is affected
Consumers who have bought or are using these products.
Media enquiries
Health Canada
(613) 957-2983
hc.media.sc@canada.ca
Public enquiries
(613) 957-2991
1-866 225-0709
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