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Fulda Unitang Herbs Sleep Plus: Unauthorized Herbal Sleep Aid May Pose Health Risks

Starting date:
August 16, 2010
Posting date:
August 16, 2010
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Product Safety, Undeclared Substance
Audience:
General Public
Identification number:
RA-110003687

The issue

Fulda Unitang Herbs Sleep Plus (pictured below), an unauthorized product promoted as an herbal sleep aid, has been found to contain high levels of the undeclared drug estazolam and may pose serious health risks to consumers. Estazolam is a prescription sedative that can impair mental alertness; it can also be habit-forming and should only be used under the supervision of a healthcare practitioner.

Who is affected

Consumers who have purchased or used Fulda Unitang Herbs Sleep Plus, including pregnant or breastfeeding women, children, the elderly, people with respiratory (breathing), kidney or liver problems, people with depression and those with a history of substance abuse; and retailers who may have this product in stock.

What consumers should do

  • Consult your healthcare practitioner immediately, before stopping use, if you are presently taking this product or have been taking it on an ongoing basis. Estazolam can be habit-forming and stopping suddenly may cause symptoms of withdrawal.
  • Avoid driving, operating heavy machinery or performing other activities requiring mental alertness until you have safely stopped taking this product.
  • Read the labelling of any health products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have a single eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label.
  • Report any side effects potentially related to this product to Health Canada (see below).
  • Return any unused product to a pharmacy for safe disposal.

What retailers should do

  • Remove this product from their stock and take to a pharmacy for safe disposal. Retailers are also encouraged to report to Health Canada if they have this product for sale by calling, toll free, 1-800-267-9675.

What Health Canada is doing

In response to a report from a consumer who experienced headache, disorientation and excessive sleepiness after taking one dose of the product, Health Canada tested a sample of Fulda Unitang Herbs Sleep Plus and found it to contain high levels of estazolam.

Health Canada has not found evidence that this product is still being manufactured or sold. As there is no expiry date on the product analyzed, Health Canada is issuing a Public Advisory as it is possible that other Fulda Unitang Herbs Sleep Plus products with no expiry date on the label may still be on store shelves or in consumers' medicine cabinets. Should Health Canada find this product on the market, Health Canada will take immediate and appropriate action.

Background

Health Canada conducted a laboratory analysis of the product and found each capsule to contain 1.8 mg of estazolam, which is roughly equivalent to the maximum daily recommended dose for healthy adults. Taking the product as directed on the label (1-2 capsules daily) may result in consuming an amount that exceeds the recommended dosage.

Estazolam belongs in the class of prescription drugs known as benzodiazepines, which should be prescribed only by a healthcare practitioner. Estazolam should not be used by people with an allergy to any benzodiazepines, such as Valium (the brand name for diazepam), Restoril (temazepam) and Ativan (lorazepam), or those individuals affected by the neuromuscular disorder myasthenia gravis or by sleep apnea. Benzodiazepines, including estazolam, should be used with caution in certain groups, including the elderly, people with respiratory (breathing), kidney or liver problems, people with depression, and those with a history of substance abuse. As well, benzodiazepines, including estazolam, are not recommended for use in pregnant or breastfeeding women or in children under the age of 18. The side-effects associated with estazolam vary according to the individual and can include headache, dizziness, drowsiness, sleep-related behaviours such as sleep-driving, behavioural changes, confusion, anxiety, depression, and breathing problems. Estazolam may interact with other drugs, including alcohol, which can lead to increased side-effects.

People can experience withdrawal symptoms when they stop taking estazolam. Withdrawal symptoms can range from anxiety and sleeplessness, to abdominal and muscle cramps, vomiting, sweating, tremors and convulsions, and are usually associated with taking higher doses of estazolam for a longer period of time.

Products affected

Fulda Unitang Herbs Sleep PlusFootnote 1

For more information

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Reporting Form and send it to us using one of these methods:

Related Health Canada Web Content

Footnotes

Footnote 1

Health Canada is aware there are products available in Canada with a similar product name, such as Sleep +. The information in this advisory applies only to the product shown in the photographs here.

Return to footnote 1 referrer

Images

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