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Public advisory

Archived – Sleep Supplements Found to Contain Habit-forming Drug

Starting date:: June 14, 2007
Posting date:: June 14, 2007
Type of communication:: Advisory
Subcategory:: Drugs
Source of recall:: Health Canada
Issue:: Undeclared Substance
Audience:: General Public
Identification number:: RA-110002026

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Health Canada is advising consumers not to use Optimum Health Care SleePlus TCM or BYL SleePlus, because the products contain the undeclared drug clonazepam, which can be habit-forming when used for as little as a few months. Consumers who may still have one of these products in their homes are advised to consult with a health care professional before they stop taking the pills, because of the risk of withdrawal symptoms.

Optimum Health Care SleePlus TCM and BYL SleePlus have different names but are the same formulation, and both products are promoted as a sleep aid. The products 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 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 clonazepam vary according to the individual and can include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.

Health Canada has issued four 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 SleePlus TCM, labelled in Chinese script, was sold to patients by Optimum Health Care, a clinic in Vancouver. BYL SleePlus was distributed to retail stores by BYL Pharmaceuticals Ltd., Vancouver. The products are being recalled; however consumers may still have the product in their homes.

Consumers who have purchased Optimum Health Care SleePlus TCM or BYL SleePlus should return it to the place of purchase. To date, no adverse reactions suspected to be associated with the use of Optimum Health Care SleePlus TCM or BYL SleePlus 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 SleePlus TCM or BYL SleePlus 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 of the Health Canada Web site.