OTTAWA - Health Canada is advising consumers not to use a product called Eden Herbal Formulations Sleep Ease Dietary Supplement, because it was found to contain an undeclared drug estazolam, which can be habit-forming when used for as little as a few months. Consumers who may still have this product in their homes are advised to consult with a health care professional before they stop taking the capsules, because of the risk of withdrawal symptoms.
Estazolam belongs in the class of drugs known as benzodiazepines, a class of drugs that should only be prescribed by a healthcare practitioner. Estazolam should not be used by people with an allergy to any benzodiazepines, such as Valium (diazepam), Restoril (temazepam) and Ativan (lorazepam), or those individuals affected by the neuromuscular disorder myasthenia gravis or by sleep apnea. Benzodiazepines, including estazolam, should only be used by pregnant women if absolutely necessary, and with caution by the elderly, and those with a history of substance abuse. The side-effects associated with the use of products containing estazolam vary according to the individual and can include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.
Eden Herbal Formulations Sleep Ease Dietary Supplement was advertised as a herbal natural health product promoted to relieve sleeping difficulty and restless leg syndrome, and is not authorized for sale in Canada.
The product Sleep Ease Dietary Supplement was distributed at the Evergreen Acupuncture Clinic in Calgary, Alberta. The clinic has stopped sale of this product and has advised all their clients who had purchased the product.
Consumers who have purchased Eden Herbal Formulations Sleep Ease 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.
Health Canada also advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find Eden Herbal Formulations Sleep Ease Dietary Supplement for sale in Canada.
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 Inquiries:
(613) 957-2991
1-866 225-0709
