Advisory
2007-16February 23, 2007For immediate release
OTTAWA - Health Canada is advising consumers not to use a product called Sleepees, 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.
The product Sleepees is advertised as an herbal sleep aid and is not authorized for sale in Canada. Sleepees is distributed by Our World Network Inc. in Vancouver, British Columbia. The distributor has stopped sale and initiated a recall of the following lots of this product: B39054006, B39069004, B39035001, B38883003, B38893003, OWN 961, OWN-042606, OWN 980, OWN 913.
Consumers who have purchased Sleepees 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 Sleepees 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.
Please note that this Advisory does not apply to Sleep-Eze, a product for which Health Canada has issued authorization to sell to Medtech products Inc.
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.
-30-
Media Enquiries:Alastair SinclairHealth Canada(613) 957-1803
Public Enquiries:(613) 957-29911-866 225-0709
