Millions of Americans take Halcion nightly to go to sleep.
After only six years on the market, the quick-acting benzodiazepine has quickly become the most frequently prescribed sleeping pill in the United States.Utah physicians routinely prescribe it; Utahns, like Americans across the country, routinely use it.
Currently, in fact, it's prescribed more than its relative, Valium, with more than 9 million prescriptions filled annually in the United States - almost half the total prescriptions for sleeping pills of any kind. Halcion's gross sales worldwide for 1988 are estimated at $265 million.
Many local physicians aren't astonished or even concerned about those statistics. Their contention is that Halcion, when prescribed and used correctly, is safe.
But a Utah attorney maintains the drug can have devastating side effects.
In potentially a landmark Utah case, Gary Pendleton, St. George, is representing Ilo Marie Grundberg, who is charged with shooting her 82-year-old mother to death.
Pendleton's principal defense is that the side effects of Halcion created a mental condition that "deprived her of the substantial capacity to appreciate the her sit uation, her mother's situation and the wrongfulness of her act."
Halcion intoxication has been asserted as a defense in a case in Michigan and is also being considered in a murder case pending in Virginia. In another national case, a former police officer was acquitted in the stabbing of his estranged wife as a result of "intoxication" arising out of his use of the drug Halcion.
Upjohn officials refused comment on these cases, other than to say that it would be "unlikely that we would be asked to be a defendant in a criminal case."
Increasing reports of Halcion's negative side effects have surfaced since 1982 when the federal Food and Drug Administration gave Upjohn Corp. the green light to market the drug.
Even prior to the approval, Dr. Theresa T. Woos, the FDA's primary medical review officer for Halcion, flashed yellow lights. Specifically, she has questioned the safety of the dosage, .5 milligrams, going on the market. She also noted that 15 deaths in foreign countries were possibly Halcion-related. Nine of the deaths were apparently suicides.
Because of documented deteriorating mental conditions among some patients, the Dutch government suspended the license for Halcion in August 1979 and has never renewed it. France and Germany have removed the half-milligram tablets from sale.
Although Upjohn still maintains that .5 milligrams at the doctor's discretion is a safe dose, earlier this year it "discontinued manufacture" of the .5 milligrams tablet worldwide.
And Upjohn's current package insert "precautions" section lists such adverse Halcion reactions as drowsiness, headaches and dizziness. The rare reactions listed include agitation, anxiety, depression, confusional states, anorexia, dry mouth, disorientation and clouding of consciousness and amnesia.
A study done by four researchers at the Sleep Research and Treatment Center and Department of Psychiatry at Pennsylvania State University College of Medicine reveals adverse reactions to Halcion at a rate almost five times higher than other commonly prescribed sleeping pills. And of the sleeping studied, amnesia is reported almost exclusively with Halcion.
"But these are rare occurrences," said Dr. Jim Walker, director of the Intermountain Sleep Disorder Center at LDS Hospital. "This (amnesia) occurs occasionally, but if there's alcohol taken in combination with the drug it magnifies this effect. For the next several hours after taking drug, a person could lose his/her memory."
Halcion is the drug of choice of the elderly because its half-life is two to five hours; it metabolizes out of the system faster than other commonly prescribed sleeping pills. Thus, it doesn't produce the sedative hangovers caused by the early benzo sleeping pills.
But some experts say that the very fact that Halcion gets out of the system so quickly may be the source of its problems. The quick exit can cause "mini-withdrawals."
Walker said withdrawal symptoms can include anxiety, rebound insomnia where sleeping difficulties worsen and sometimes panic.
"If a person did irrational things ordinarily, he might then do irrational things," Walker said. "But the main problem is that he wouldn't have any memory of what he did."
Dr. Daniel D. Christensen, a clinical professor of psychiatry at the University of Utah Medical School, agrees. He also says that the phenomenon of "disinhibition," that occurs with other sedative medications and alcohol also applies to Halcion.
"If someone has a hostile or angry side to begin with, benzodiazepines may disinhibit that anger," he said. "But I have never seen anyone become psychotic from taking Halcion."
Nor has Christensen treated a Halcion addiction. He said only two patients have been hospitalized for Halcion addiction at the Western Institute of Neuropsychiatry, where he's medical director.
"It's not a common everyday type of thing," he said. "And, as a general rule, people aren't bothered by the drug's side effects."
While acknowledging that people have different reactions to different drugs, the local specialists maintain that Halcion is safe when used and prescribed correctly.
"This is not the kind of thing you prescribe and renew, renew, renew, and people are on it for several months or years," Christensen said. "That's not the intention of this medication. This is best used in short-term situational crisis where people need to have help sleeping.
"If one uses this more than 3-4 times a week on a regular basis, the body forms a dependency to it. In that way it is really no different than Valium, alcohol, or any of the other minor tranquilizer medicines that people may take. This medication is misused when it is given night after night for months or years."
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