Advisory
2006-82
August 30, 2006
For immediate release
OTTAWA - Health Canada is advising consumers not to use Salt Spring Herbals Sleep Well Dietary Supplement because a sample analyzed by Health Canada has been found to contain the undeclared drug estazolam, a sedative that can be habit-forming when used for as little as a few months. Consumers already taking this product should consult with a health care professional before they stop taking the capsules, since symptoms of withdrawal are possible. A recall has been initiated by the Canadian distributor.
Salt Spring Herbals Sleep Well Dietary Supplement capsules are advertised as a herbal natural health product to relieve insomnia and restless leg syndrome. The most common side-effects associated with the use of products containing estazolam are dizziness and drowsiness. More serious side-effects include loss of memory, hallucinations, confusion and depression.
Drugs in the same class (benzodiazepine) as estazolam can only be prescribed by a physician. Estazolam should not be used by people with an allergy to other benzodiazepines (such as Valium, Restoril and Ativan), or those affected by the neuromuscular disorder myasthenia gravis or sleep apnea. Estazolam should be used with caution by pregnant women, the elderly, and those with a history of substance abuse.
Consumers who have purchased Salt Spring Herbals Sleep Well Dietary Supplement capsules should return the product to the place of purchase. To date, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.
This product has been found on the Canadian market but is not authorized for sale in Canada. The Canadian distributor, Salt Spring Herbals in British Columbia, is recalling the product based on preliminary findings with one package, and Health Canada is conducting additional tests to determine the source of the undeclared drug. Health Canada will update this advisory as more information becomes available.
Health Canada also advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find Salt Spring Herbals Sleep Well Dietary Supplement for sale in Canada.
Please note that this Advisory does not apply to Nova Sleep Well, a melatonin-containing natural health product for which Health Canada has issued an authorization to sell (NPN 80001443) to NHP Research and Consulting Co. of Richmond, B.C.
Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to this or any other health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
CADRMP
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
email: cadrmp@hc-sc.gc.ca
The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located on the MedEffect portal of the Health Canada Web site.
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Media Inquiries:
Paul Duchesne
Health Canada
(613) 954-4807
Public Inquires:
(613) 957-2991
1-866 225-0709
