With more than 7 million prescriptions a year in the U.S., Halcion is the most widely used sleep medication—and among the most controversial drugs in use today. In October 1991, Britain banned its sale, citing a "much higher frequency of psychiatric side effects, particularly memory loss and depression," compared with similar drugs. On May 18 an advisory panel of the Food and Drug Administration, responding to charges that Upjohn Co., Halcion's manufacturer, had downplayed or ignored studies that suggested the drug produced serious side effects, will hold a hearing on the safety of the drug.
To assess the controversy, correspondent Liz McNeil spoke with Dr. Stuart Yudofsky, 47, chief of psychiatry at Houston's Methodist Hospital and chairman of the Psychiatric Department at Baylor College of Medicine. Yudofsky is also the author of What You Need to Know About Psychiatric Drugs (Grove Weidenfeld).
Given the possibility of disorienting side effects, is there reason to question President Hush's use of Halcion?
Since I am not the President's physician, I cannot make any comments about him specifically. But in general, I believe anyone over age 65 who uses Halcion should do so with extreme care. [Bush is 67.] Older people tend to be much more sensitive to all psychoactive drugs and might exhibit more side effects.
What, exactly, is Halcion?
Halcion is a benzodiazepine, a broad class of medications including Restoril, Valium and Xanax, which affect receptors in the brain involving anxiety and alertness. Halcion metabolizes quickly, within four to six hours, and, unlike other insomnia drugs, does not usually result in daytime drowsiness. The drug first appeared on the market in 1983.
What are Halcion's adverse side effects?
Halcion, like other benzodiazepines, can impair memory and affect orientation. But because Halcion is so potent and often given in too strong a dose, memory lapses are more common than with other benzodiazepines. It can also react dangerously with alcohol and recreational drugs, causing lightheadedness, poor judgment, a decreased attention span and an artificial sense of safely. And it can intensify preexisting conditions, such as depression and irritability.
Several FDA studies in the late '80s found that Halcion generated anywhere between eight to 45 times as many adverse reaction reports as two other popular sleeping drugs. How do you explain this?
In part this is due to the fact that Halcion is prescribed more often than any other benzodiazepine. Also Halcion has a narrow margin of safety between the dose that gives the therapeutic effect and the dose that brings on side effects. Until recently, Halcion was recommended and used in doses as high as 0.5 mg. That has been reduced to 0.25 mg, but I believe that a dose of 0.125 is sufficient for most adults—a fourfold reduction from the initial dosage. Think of the difference between drinking three beers and two six-packs.
Is Halcion addictive?
All benzodiazepines are potentially addictive. I think Halcion is a useful drug, but I wouldn't prescribe it if a patient had abused alcohol, so-called recreational drugs or other types of prescription drugs, like barbiturates.
Why are benzodiazepines so widely prescribed?
My own opinion is that they are overprescribed. However, they are safer than barbiturates, which were used before as sleep medications. Barbiturates are far more addictive than benzodiazepines. When barbiturates are stopped suddenly, people have very severe withdrawal symptoms, such as seizures. Taken in high doses, with or without alcohol, barbiturates can be lethal.
Could Halcion increase a person's potential for violence?
All benzodiazepines reduce inhibitions, just as alcohol does, but we're talking about feelings that already exist. There is no proof that when prescribed correctly—with careful attention to dosage and the patient's physical condition—that Halcion is more or less dangerous than any other benzodiazepine.
What general precautions should be taken with Halcion?
First, a physician must try to understand the reasons for a patient's insomnia, then be sure there are no nonmedical treatments that would work, such as a change in diet. Halcion should only be taken under a physician's close supervision. If the medication is prescribed beyond several days, the patient should understand why. If a patient notices side effects, he should contact his doctor. Patients should also be careful not to combine this medication with am other drug without approval from their doctor nor to combine it with alcohol.
Should sales of Halcion be curtailed?
I don't believe that medications such as Halcion, which have such potential to help people, should be removed from the market without clear, specific scientific data. So far, the evidence against Halcion is not sufficiently convincing to justify denying it to the many people who benefit from it now. We should not blame medication that has value because it has been misapplied.
In 1988 a Utah woman shot her 83-year-old mother dead. Her defense: Her insomnia drug, Halcion, had made her paranoid. The murder case was dismissed. In January, President Rush collapsed during a trip to Asia and struck many observers as unusually inarticulate during a campaign trip to New Hampshire two weeks later. Some commentators suggested that his use of Halcion might have been a factor. (The President's personal physician, Dr. Burton J. Lee III, denied this but said that because of the controversy over the drug, Bush would avoid taking it.) And recently Burt Reynolds revealed that he lapsed into a coma while attempting to end abruptly his heavy use of Halcion—taken to dull the pain of a broken jaw.