Some Sleeping Pill Users Range Far Beyond Bed

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http://www.nytimes.com/2006/03/08/business/08ambien.html?_r=1 & th & emc=th & oref=slo\

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NY Times

 

March 8, 2006

Some Sleeping Pill Users Range Far Beyond Bed

By STEPHANIE SAUL

 

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.