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Some Sleeping Pill Users Range Far Beyond Bed
With a tendency to stare zombie-like and run into stationary objects, a new species of impaired motorist is hitting the roads: the Ambien driver.
Ambien, the nation's best-selling prescription sleeping pill, is showing up with regularity as a factor in traffic arrests, sometimes involving drivers who later say they were sleep-driving and have no memory of taking the wheel after taking the drug.
In some state toxicology laboratories Ambien makes the top 10 list of drugs found in impaired drivers. Wisconsin officials identified Ambien in the bloodstreams of 187 arrested drivers from 1999 to 2004.
And as a more people are taking the drug — 26.5 million prescriptions in this country last year — there are signs that Ambien-related driving arrests are on the rise. In Washington State, for example, officials counted 78 impaired-driving arrests in which Ambien was a factor last year, up from 56 in 2004.
Ambien's maker, Sanofi-Aventis, says the drug's record after 13 years of use in this country shows it is safe when taken as directed. But a spokeswoman, Melissa Feltmann, wrote in an e-mail message, "We are aware of reports of people driving while sleepwalking, and those reports have been provided to the U.S. Food and Drug Administration as part of our ongoing postmarketing evaluation about the safety of our products."
A spokeswoman for the F.D.A. said the drug's current label warnings, which say it should not be used with alcohol and in some cases could cause sleepwalking or hallucinations, were adequate. "People should be aware of that," said the spokeswoman, Susan Cruzan.
While alcohol and other drugs are sometimes also involved in the Ambien traffic cases, the drivers tend to stand out from other under-the-influence motorists. The behavior can include driving in the wrong direction or slamming into light poles or parked vehicles, as well as seeming oblivious to the arresting officers, according to a presentation last month at a meeting of forensic scientists.
"These cases are just extremely bizarre, with extreme impairment," said Laura J. Liddicoat, the forensic toxicology supervisor at a state-run lab in Wisconsin who made the presentation.
Her presentation, which reported on six of the cases, was made at a meeting of the American Academy of Forensic Sciences, where her counterparts from other parts of the country swapped similar tales.
Several of Ms. Liddicoat's cases involved drivers whose blood revealed evidence of Ambien overdoses. In one of them the driver, who was also taking the antidepressant citalopram, crashed into a parked car, was involved in another near collision, then drove over a curb. When confronted by police, he did not recall any of the recent events, according to the presentation.
Ms. Liddicoat did not describe any of those cases as sleep-driving — in fact, she said she had not heard of that defense — and it is possible that some drivers' claims of driving while asleep may be mere Ambien alibis. But some medical researchers say reports of sleep-driving are plausible.
Doctors affiliated with the University of Minnesota Medical Center who have studied Ambien recently reported the cases of two users who told doctors they sleep-drove to the supermarket while under the drug's influence. Neither of the patients remembered the episode the next day, according to Dr. Carlos Schenck, an expert in sleep disorders who is the lead researcher in the study.
"Luckily, neither of them got hurt," said Dr. Schenck, who added that sleep-driving — which really occurs in a twilight state between sleep and wakefulness — was more common than people generally suspect. He said he believed that Ambien was an excellent sleep agent, but that patients need to be better warned about its potential side effects.
The traffic cases around the country include that of Dwayne Cribb, a longtime probation and parole officer in Rock Hill, S.C. Mr. Cribb says he remembers nothing after taking Ambien before bed last Halloween — until he awoke in jail to learn he had left his bed and gone for a drive, smashed into a parked van and driven away before crashing into a tree. Mr. Cribb is still facing charges of leaving the scene of an accident.
A registered nurse who lives outside Denver took Ambien before going to sleep one night in January 2003. Sometime later — she says she remembers none of the episode — she got into her car wearing only a thin nightshirt in 20-degree weather, had a fender bender, urinated in the middle of an intersection, then became violent with police officers, according to her lawyer.
The woman, whose lawyer says she previously had a pristine traffic record, eventually pleaded guilty to a reduced charge of careless driving after the prosecutors partly accepted her version of events, said the lawyer, Lloyd L. Boyer.
Many states do not currently test
for Ambien when making impaired- driving arrests. But a survey
still under way by a committee from the forensic sciences group
and the Society of Forensic Toxicologists found that among
laboratories that conduct tests of drivers' blood samples for two
dozen states, 10 labs list Ambien among the top 10 drugs found in
impaired drivers, according to Dr. Sarah Kerrigan, a forensic
toxicologist in Houston involved in that survey.
Ms. Liddicoat, in Wisconsin, is among experts who suggest that
Ambien may need a stronger warning label. Others arguing that case
include doctors, Ambien users and defense lawyers.
"Doctors are handing out these drugs like Pez," said William C.
Head, an Atlanta lawyer who is one of the nation's leading defense
lawyers specializing in impaired-driving cases.
The F.D.A., which would have to order any labeling changes, says
it is not aware of any pattern of problems with the drug. Still
Ms. Cruzan, in response to a reporter's question, said the agency
would look into unusual sleepwalking episodes.
Including the notifications from Sanofi, which as a matter of
policy the F.D.A. declined to discuss, the agency did receive 48
"adverse event" reports in 2004 involving Ambien use without other
drugs. They involved three cases of sleepwalking, six reports of
hallucinations and one traffic accident.
Ambien's competitors - Lunesta by Sepracor and Sonata by King
Pharmaceuticals - are not as widely used in this country, and do
not seem to be cropping up with any frequency on police blotters.
Ambien sales last year reached $2.2 billion, according to IMS
Health. Among the three drugs, Ambien accounted for 84 percent of
prescriptions dispensed.
A federal prosecutor was persuaded that Ambien played a part in a
well-publicized case last summer involving not a car but an
airliner. A US Airways flight from Charlotte, N.C., to London last
July was diverted to Boston, after a passenger who had taken
Ambien became "like the Incredible Hulk all of a sudden,"
according to his lawyer.
The man, Sean Joyce, a British painting contractor, became
agitated, tore off his shirt and threatened to kill himself and
fellow passengers, according to court documents. If convicted, Mr.
Joyce could have faced a maximum sentence of 20 years in jail for
interfering with a flight crew, according to his lawyer, Michael
C. Andrews.
But under a plea agreement Mr. Joyce was sentenced to five days
already served, after the prosecutor accepted his story that his
eruption, which he said he could not recall at all, occurred as a
result of taking one Ambien pill and drinking two
individual-serving bottles of wine.
Many of the impaired-driving cases involve people who drank
alcohol before taking Ambien. Mr. Cribb, for instance, said he had
two beers with dinner before he took the drug and went to bed.
Sanofi-Aventis says that while sleepwalking may occur while taking
Ambien, the drug may not be the cause. It also notes that the
warnings with Ambien, including those in its television ads,
specifically instruct patients not to use it with alcohol and to
take it right before bed.
Alcohol has sometimes been shown to cause sleepwalking, and it can
also magnify Ambien's effects, according to Dr. Mark Mahowald,
director of the Minnesota Regional Sleep Disorders Center at
Hennepin County Medical Center, who is also involved in Dr.
Schenck's study.
In the past, the center has received grant funding from Sepracor,
Lunesta's maker, but Dr. Mahowald said that none of the
researchers currently received any funding from sleeping pill
companies.
Ambien's alcohol warning is apparently ignored by many people. But
Mr. Head, the defense lawyer, says he has concluded that no one
should take Ambien the same evening they have been drinking
alcohol. "Not even a toast," he said.
Mr. Head is now defending a man in Decatur, Ga., who, after having
three drinks one night, said he took two Ambien and was in bed
watching David Letterman's monologue on television. Without
realizing it, the man says, he got back out of bed and behind the
wheel and was arrested on multiple charges that included driving
on the wrong side of the road.
Too many other people taking Ambien also evidently disregard the
other label guidelines.
Ann Marie Gordon, manager of Washington State's toxicology lab,
said that many of those arrested reported that they took Ambien
while driving so it would "kick in" by the time they got home.
"Hello - it kicked in before you got home?" Ms. Gordon said.
"That's not a good thing. I'm amazed at the number of people who
do that."
But misuse of the drug may not explain all the cases. The nurse
near Denver took a single Ambien and went to bed, according to her
lawyer, Mr. Boyer of Englewood, Colo. Mr. Boyer said that only
when the woman returned home after her arrest did she discover a
partly consumed bottle of wine on her counter - unopened when she
went to bed, she said - leading her to suspect she had begun
drinking after taking Ambien.
Research by Dr. Schenck and others elsewhere have found evidence
that Ambien users engaged, unawares, in various
middle-of-the-night behaviors. In a study published in 2001,
researchers at the Mayo Clinic Sleep Disorders Center reported on
five cases of unusual nighttime eating, sometimes while
sleepwalking, in patients taking Ambien. The chief of physical
medicine and rehabilitation for the VA North Texas Health System
in Dallas, Dr. Weibin Yang, said he became aware of Ambien's
potential side effects while at another hospital treating a
55-year-old patient after hip surgery.
The man, who had no history of sleepwalking, walked into a
hospital corridor one night, where he urinated on the floor. On
another night, he got out of bed and told nurses he was going to
church. Dr. Yang said the patient was also taking other
medications, but the sleepwalking stopped when Ambien was
discontinued. The patient, he said, had no recollection of either
event.
Dr. Yang said such experiences persuaded him that people could
drive, without realizing it, after taking Ambien.
Meanwhile in South Carolina, Mr. Cribb, who has already pleaded
guilty to driving under the influence, still faces a charge of
leaving the scene of an accident. He says he has sworn off Ambien.
"There has to be a stronger warning," he said, "about what this
drug does to you."
Ron Nixon contributed reporting for this article.
This information is courtesy of http://www.nytimes.com/
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