United States of America. The Food and Drug Administration has warned consumers not to purchase or consume a product known as "Sleeping Buddha".
The FDA has determined that the product actually contains the prescription-strength drug ingredient, estazolam, a benzodiazepine sedative which is known to have serious adverse effects, including the potential to cause fetal damage if a pregnant woman consumes the drug.
"Sleeping Buddha" is marketed in capsule form as a product of China and labelled as imported and distributed by Treasure Box Products Inc., a Canadian company. The product is being promoted for insomnia and restlessness and is sold as a herbal alternative to prescription medicines.
Also, because this product is a sedative, it poses a special risk to consumers who take it while driving, while operating heavy machinery or while taking other sedative drugs or alcohol.
The 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 has initiated a voluntary recall of all their products sold in the United States. The FDA is monitoring this recall in conjunction with Canada's Therapeutic Products Directorate.
References: Press Office Statement, FDA, dated 10 March 1998.