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