U.S. Doctors Lose No Sleep Over Halcion : Health: Although the British have banned the anti-insomnia drug, American experts say it is safe if used with care in proper dosages.
American doctors who treat people with insomnia say they are perplexed by the British government’s decision last week to withdraw the popular sleeping drug Halcion from the market, citing a high risk of potentially dangerous side effects.
According to several veteran sleep-disorder experts, the tales of violent behavior and paranoia that some patients have blamed on Halcion are not supported by American doctors’ extensive experience in prescribing the drug or by clinical studies.
Although experts encourage further studies and caution against excessive dosage, they say people taking Halcion without difficulty need not be concerned.
For them, “I don’t see any point in discontinuing it,” says Dr. Dennis Munjack of the USC anxiety disorders clinic. “I don’t think I’m going to change my prescribing practices.”
Although many U.S. experts caution that the British government may have new scientific evidence on Halcion that American practitioners do not, they blame the Halcion hysteria on other factors:
* A few anecdotal reports of serious side effects produced by the drug that resulted in high-profile murder trials and lawsuits against the manufacturer, Upjohn Co.
* The American public’s belief that drugs should be generally free of side effects.
* Some misuse of the drug because of sloppy prescribing practices, including excessive doses and duration.
Side effects commonly associated with Halcion include drowsiness, headache, dizziness, nervousness, lightheadedness, coordination disorders, nausea, vomiting, euphoria, rapid heart beat, memory impairment, cramps and pain, depression and visual disturbances.
More recently, Halcion has been linked to short-term amnesia. In addition, it is thought to be more potent for the elderly.
In patients of any age, it can cause a “rebound” effect in which those who suffer depression or anxiety might find their condition worsened after the drug wears off. For this reason, Halcion is typically not recommended for people with such disorders.
Still, none of Halcion’s typical side effects is considered especially worrisome, experts say. These potential reactions are typical of other drugs in Halcion’s chemical family--the benzodiazepines--which include the insomnia drug Dalmane and the anxiety drugs Valium and Xanax.
But some Halcion users have also reported more dangerous side effects, including violent behavior, suicidal thoughts and paranoia.
“There has been considerable discussion recently about Halcion . . . that its risk-benefit ratio was not favorable. But this has not been borne out by any objective studies that I’m aware of,” says Dr. Philip Westbrook, director of the Sleep Disorders Center at Cedars-Sinai Medical Center.
Sleep-disorder experts seem more concerned that the steam-rolling negative publicity might lead the U.S. government to withdraw the drug. Food and Drug Administration officials say they will review safety data on Halcion and confer with British authorities regarding that country’s ban.
But so far, there are no indications that Halcion will be withdrawn in this country.
“I think it would be a real shame to lose the drug,” says Dr. Daniel Robinson, chairman of the department of clinical pharmacy at the USC School of Pharmacy. “I think it’s very effective. However, I think we need better education on how to use it.”
Physicians say they are unable to explain why Halcion, which is available in 90 countries, is dogged by a negative reputation while soaring to worldwide popularity as the most commonly prescribed drug for insomnia. Sales topped $250 million in 1990, according to Nancy Laffen, a spokeswoman for Upjohn.
The drug originally was marketed in Europe in doses up to 1 milligram, but Upjohn stopped making 1-milligram and 0.5-milligram tablets because of unfavorable reports of side effects. Halcion is available in 0.125 milligram and 0.25 milligram doses, but larger doses are considered a “viable option for patients resistant to lower doses,” Laffen says.
In recent years several legal cases have questioned the drug’s effects, and several individuals accused of murder have claimed that Halcion led them into their violent behavior. In one highly publicized Utah case, a woman was accused of murdering her mother; charges against her were dropped after expert testimony that she had been under the influence of Halcion and had not acted voluntarily. The woman sued Upjohn and reached an out-of-court settlement.
The company still faces several lawsuits charging adverse reaction to the drug, as well as opposition from the Public Citizen Health Research Group, a consumer watchdog group founded by activist Ralph Nader.
In his 1991 book “Women’s Health Alert,” Dr. Sidney Wolfe, director of the Nader group, concludes: “We do not recommend the use of this dangerous drug.”
Prompted by Wolfe’s organization and reports of adverse reactions, the Food and Drug Administration asked Upjohn in 1990 to revise its Halcion label to warn of problems with amnesia. But the agency apparently has remained unconvinced that the drug poses special dangers.
Halcion is considered an improvement over other sleeping medications because its effects last only about three hours. Patients also consistently report that it does not produce a “hangover” the next day--that is, the feeling of drowsiness or lethargy commonly experienced with other sleeping medications.
Halcion is commonly prescribed for short-term treatment of insomnia, typically a temporary, stress-induced insomnia, says Westbrook. This type of insomnia can take the form of difficulty in falling asleep, frequent awakening during the night or waking too early in the morning.
The drug also is often prescribed for jet lag. Scripps Clinic researcher Milton Erman, in France last week for a meeting of sleep disorders researchers, says he conducted a survey on how the physicians handle jet lag. Of those who said they took a sleeping pill, 75% said it was Halcion, he reports.
When he returned home from his intercontinental flight last week, Erman says, a tiny dose of the medication helped him overcome the exhaustion and irritability of jet lag to return to a full, busy schedule.
“I slept well and woke up feeling well,” says Erman, who directs the division of sleep disorders at the La Jolla clinic.
Westbrook says he also has used the drug when a hectic, high-pressure schedule interferes with his need for a good night’s sleep and the ability to function well the next day.
“When I don’t want to have any carry-over (of drowsiness) the next day, (Halcion) fits the bill,” he says. “In that kind of situation, it’s a useful drug.”
Some experts say Halcion might actually be the least abused of the class of tranquilizers called benzodiazepines, which are widely criticized for overuse.
“All of (the benzodiazepines) can be misused, in that they can be taken at a higher doses,” Erman says. “Halcion patients might take it, and it would wear off in a few hours and they would take a second dose. But other than that, these really aren’t very abusable drugs.”
Still, Westbrook cautions that anyone who consumes any drug is at risk for possible side effects--and Halcion, he says, is no different.
“It is part of the American psyche these days that they want everything perfect,” he notes. “Aspirin has significant side effects. Any medication that is going to be effective at all probably has side effects.”
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