FDA Issues Warning About "Sleeping Buddha"

March 11, 1998
Web posted at: 5:07 a.m. EST (1007 GMT)

ROCKVILLE, Maryland (Reuters) -- The U.S. Food and Drug Administration warned consumers Tuesday not to purchase or use an over-the-counter product called "Sleeping Buddha" because it contains an unlabeled prescription drug ingredient "...that poses possible health risks," according to an FDA statement.

Sleeping Buddha, marketed as an herbal alternative to prescription sleep aids, actually contains the prescription-strength drug estazolam, from the benzodiazepine family of drugs.

According to the FDA, estazolam can cause damage to a fetus if a pregnant woman takes it. And, because it is a potent sedative, it may pose a risk to people who drive, operate heavy machinery, or drink while taking the drug.

A week ago, the FDA convinced Sleeping Buddha's distributor, Treasure Box Products, Inc. of Burnaby, British Columbia, to recall the product.

But the agency is concerned that some consumers may still have Sleeping Buddha in their medicine cabinets, and is warning them against continued use.

The FDA said it had not received any reports of injuries or adverse reactions as a result of Sleeping Buddha ingestion. But the federal agency advises consumers who have used the product and have concerns to consult their physician.

Related stories:

• FDA wants warning labels for some herbal supplements - June 3, 1997
• FDA seeks Justice probe of Halcion sleeping pill - May 31, 1996
• FDA withholding data on sleeping pill - May 23, 1996

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