The Dark Side of Halcion

By Christine Gorman

When Halcion was first approved for sale in the U.S. in 1982, doctors thought they had found the perfect sleeping pill. Like its chemical cousins Librium and Valium, it was safer than barbiturates. As an added bonus, Halcion did not linger in the body the way most of its predecessors did, and therefore it did not leave people groggy the next day. Within a few years, the drug, produced by Upjohn of Kalamazoo, Mich., became the most prescribed sleeping pill in the world. In 1990 American pharmacists filled more than 7 million orders. Satisfied customers include Secretary of State James Baker, who finds Halcion handy on long plane trips. "Time for a blue bomb," he sometimes announces before naps, referring to the color of a 0.25-mg Halcion pill.

Like most drugs, however, Halcion has a dark side after all. In the mid- 1980s, the U.S. Food and Drug Administration began receiving more and more reports of side effects from the drug -- everything from amnesia to agitation. The increase could be explained by the rising number of people taking Halcion, but the drug got some bad publicity when a Utah woman killed her mother while on Halcion and sued the manufacturer. Upjohn settled the case out of court, all the while denying that the drug was to blame for the murder.

Now Halcion is facing its most serious challenge yet. Last week the British Department of Health banned sales of the drug in Britain, citing new evidence that the pill "is associated with a much higher frequency of side effects, particularly memory loss and depression," than similar medications. Soon afterward, the FDA promised to take a much closer look at the drug.

Already the British ban is proving just as controversial as the drug. Many researchers contend that the media have exaggerated Halcion's dangers. "This is sensationalism at its worst," says Dr. James Walsh, president of the American Sleep Disorders Association. "There is no scientific justification for this action." But at least a few scientists believe Halcion should be banned in the U.S. "It's clear that this is a dangerous drug," says Dr. Anthony Kales of the Pennsylvania State University College of Medicine.

Halcion acts on the brain's limbic system, which plays a major role in the genesis of sleep and the emotions. Because it lasts in the body only a matter of hours, it can trigger a boomerang effect, unleashing the very anxiety it was meant to tame. Adverse reactions become more common the higher the dose. Doses of as much as 1.0 mg were once prescribed in Europe, but the recommended dose is now only 0.25 mg. In most cases where Halcion has allegedly been linked to violent behavior, the people took more than is deemed safe, had been drinking alcohol, or had been on the drug for a long period of time.

Physicians cannot prevent patients from taking more tablets than instructed. But following all the publicity about the abuse of Valium in years past, doctors should be more alert to the dangers of overreliance on tranquilizers and sleeping pills. Even if the FDA does not find the evidence against Halcion strong enough to ban the drug, it should be used less cavalierly.

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CREDIT: TIME Graphic

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With reporting by William Mader/London and Andrew Purvis/New York