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Public advisory

Archived – Health Canada advises consumers not to use herbal sleep supplement Sleepees, which contains a habit-forming drug

Starting date:
February 23, 2007
Posting date:
February 23, 2007
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public
Identification number:
RA-110001801

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 website.

 

Archived - Sleep supplement found to contain habit-forming drug

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Archived – Sleep Supplements Found to Contain Habit-forming Drug

2007-06-14 | Health products

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Media enquiries

Alastair Sinclair

Health Canada

613-957-1803

Public enquiries

613-957-2991

1-866-225-0709