P. M. BRIEFING : FDA Tells Concerns on Sleeping Pill

Food and Drug Administration officials said today they are worried by the pattern of side effects reported by users of Halcion, the world’s best-selling sleeping pill, and said they wanted advice from a panel of outside experts.

Charles Anello, an FDA official, said reports of amnesia, anxiety, hallucinations, confusion, intentional injury and seizures have been recorded for Halcion far out of proportion to the drug’s market share. Halcion, triazolam in tablet form, is made by Upjohn Co. of Kalamazoo, Mich.

“Halcion has been the subject of recurring waves of adverse reports since its introduction into the domestic market,” Dr. Paul Leber of the FDA staff told the agency’s Psychopharmacological Drugs Advisory Committee.

Leber said the agency staff is seeking the outside panel’s advice because it does not know how to interpret the side effect reports. He said the FDA Advisory Committee could react in a variety of ways, from banning the drug to doing nothing.