OTTAWA - Health Canada is advising consumers not to use the sleep supplement product Optimum Health Care Sleep Easy, because it contains the undeclared drug clonazepam, 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 pills, because of the risk of serious withdrawal symptoms.
Optimum Health Care Sleep Easy has a different name but has the same formulation as Optimum Health Care SleePlus TCM and BYL SleePlus, which were the subject of a Health Canada public advisory issued on June 14, 2007. All of these products are promoted as sleeping aids and are not authorized for sale in Canada.
Clonazepam belongs in the class of drugs known as benzodiazepines, which should only be prescribed by a health care professional. Clonazepam 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 clonazepam, should not be used by pregnant women unless absolutely necessary, and used with caution by the elderly and those with a history of substance abuse. The side-effects associated with the use of products containing clonazepam vary according to the individual and can include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.
Health Canada has issued four other advisories on similar products since August 2006. Eden Herbal Formulation Serenity Pills II, Salt Spring Herbals Sleep Well Dietary Supplement, Sleepees and Eden Herbal Formulations Sleep Ease Dietary Supplement were advertised as herbal health products to relieve sleeping difficulty, and were found to contain the undeclared drug estazolam, also in the class of drugs known as benzodiazepines. None of these products have been authorized for sale by Health Canada. Drugs and natural health products that are authorized for sale in Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.
Optimum Health Care Sleep Easy was sold to patients by Optimum Health Care, a clinic in Vancouver. The product is being recalled; however consumers may still have the product in their homes.
Consumers who have purchased Optimum Health Care Sleep Easy should return it to the place of purchase. To date, no adverse reactions suspected to be associated with the use of Optimum Health Care Sleep Easy 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 Optimum Health Care Sleep Easy 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 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
Ottawa, Ontario, AL 0701C
K1A 0K9
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 portal of the Health Canada Web site.
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Media Inquiries:
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
1-866 225-0709
