Press Office
Food and Drug Administration
U.S. Department of Health and Human Services

STATEMENT                       Ivy Kupec:           301-827-6242
March 10, 1998                  
                                Consumer Inquiries:  800-532-4440

FDA WARNS CONSUMERS AGAINST TAKING DIETARY SUPPLEMENT "SLEEPING BUDDHA"

The Food and Drug Administration is warning consumers not to purchase or consume a product known as Sleeping Buddha. The product, which is being marketed as a dietary supplement, contains an unlabeled prescription drug ingredient that poses possible health risks. The product also has not been submitted to FDA for review or approval for any of the uses for which it is being sold.

Sleeping Buddha is marketed in capsule form as a product of China and labeled as imported and distributed by Treasure Box Products Inc. of Burnaby, B.C., Canada. The product is being promoted for insomnia and restlessness and is sold as an herbal alternative to prescription sedatives.

FDA has determined that the product actually contains the prescription-strength drug ingredient, estazolam, which is a sedative of the benzodiazepine family. Estazolam is known to have serious side effects, including the potential to cause fetal damage if a pregnant woman consumes the drug.

Also, because this product is a sedative, it poses a special risk to consumers who take the drug while driving, while operating heavy machinery, or while taking other sedative drugs or alcohol.

FDA has not received any reports of injury or adverse reactions from this product. However, all consumers, and especially pregnant women, should be aware of the risks associated with this product.

Treasure Box Products Inc., in response to U.S. and Canadian government testing, has initiated a voluntary recall of all their products sold in the United States. FDA, in conjunction with Canada's Therapeutic Products Directorate, will be monitoring this recall.

Consumers who have used this product and have medical concerns should consult with their health care providers.

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