To Sleep, Perchance to . . . Walk Is Ambien Sleepwalking Understated?

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To Sleep, Perchance to . . . Walk

Reports Raise Questions About Sleeping Pill Side Effect.

Is Ambien Sleepwalking Understated?

 

By Martin F. Downs

Special to The Washington Post

Tuesday, March 14, 2006; Page HE01

 

The most prescribed sleep medication in the United States may be

linked to episodes of sleepwalking and related strange and dangerous

behaviors, experts say -- including incidents of nocturnal eating,

phone conversations, shoplifting and even driving -- of which the

subject has no memory.

 

Sleep specialists and researchers cite a growing though still

inconclusive body of reports associating Sanofi-Aventis's drug

Ambien with the incidents. More than 24 million prescriptions for

Ambien were written in 2004.

 

 

 

There is no reliable estimate of how many Ambien users sleepwalk,

and no one knows who might be at risk. The prescribing information

for Ambien lists somnambulism as a " rare side " effect, meaning that

it has been reported in fewer than one in 1,000 patients. (Photo

Illustration By Bill O'Leary - The Washington Post)

 

Ambien and Sleepwalking Risk

· Sleep researchers have reported an unusual number of incidents of

sleepwalking in people taking Ambien, the top-selling sleep aid in

the U.S. The Food and Drug Administration has received similar

reports. Some incidents involve eating or driving while asleep; some

have led to criminal charges. No...

 

 

Transcript

Sleep Medicine and Disorders

Michael Sateia, chief of the Section of Sleep Medicine at Dartmouth-

Hitchcock Medical Center in Lebanon, N.H., fielded questions and

comments about sleep disorders and the reported possible side

effects of Ambien, the most prescribed sleep medication in the

United states.

 

 

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Timothy Morgenthaler, a researcher at the Mayo Clinic Sleep

Disorders Center in Rochester, Minn., says he has seen many cases of

people who sleepwalk and sleep-eat after taking Ambien.

 

He described five such cases in a 2002 report in the journal Sleep

Medicine. All those patients stopped having sleep-eating episodes

when they discontinued Ambien, Morgenthaler said. Since then he has

seen many similar cases, he said.

 

" I feel pretty comfortable that this is a real phenomenon, " he said.

 

Sanofi-Aventis, the French maker of the drug, declined to make

officials available for interviews. The company issued a statement

saying the side effect is known but rare, and that " when taken as

prescribed, Ambien is a safe and effective treatment for insomnia. "

The side effect is disclosed in the product's full labeling

material, where it is cited among numerous central nervous system

side effects.

 

Other case reports of Ambien-related sleepwalking have been

published in medical journals, and researchers of the Minnesota

Regional Sleep Disorders Center reported 19 additional cases at a

medical conference last year.

 

Reports made to the Food and Drug Administration (FDA) by doctors

and patients show more sleepwalking incidents associated with Ambien

than with all other sleep aids combined.

 

None of these observations proves Ambien causes sleepwalking, and

questions about the side effect were not raised during the FDA's

preapproval review of the scientific data. The agency approved the

drug in 1993.

 

Ambien and other newer sleep drugs are considered safer than

previous types, in that they are believed to be less addictive and

less toxic even in overdose.

 

Sleepwalking Claims

 

 

 

---

-----------

 

 

The case of lifelong insomnia sufferer Janet Makinen is typical of

the Ambien incidents.

 

The 55-year-old resident of Dade City, Fla., said she took Ambien

nightly for six years. During that time, she regularly got out of

bed after having fallen asleep, went to the kitchen and ate, she

said.

 

" I went from wearing a size 1 to wearing a size 12, " Makinen

said. " I would eat raw eggs. I would eat a half-gallon of ice cream.

I would eat a bag of potato chips, a loaf of bread. "

 

She would find evidence of her night eating afterward, she said, but

had no memory of doing it.

 

Makinen, identified via an Internet message board where people share

Ambien stories, was interviewed late last year. She has since become

a plaintiff in a class-action lawsuit against Sanofi-Aventis filed

in federal court on March 6.

 

Others involved in the lawsuit face criminal charges for things they

have done while they say they were sleepwalking on Ambien, including

driving and shoplifting. One alleges she was twice sexually

assaulted after taking Ambien, and has only partial memories of the

incidents.

 

Susan Chana Lask, a New York lawyer who represents the plaintiffs,

says that besides seeking damages, they hope to force the drug

company to provide stronger cautions about sleepwalking. " People

need to know about the risks of serious problems associated with

this drug, " she said.

 

Sanofi Aventis declined to comment on the suit, which a spokesman

said the company had not seen.

 

Dozens of Ambien users have reported being involved in auto

accidents they do not remember, according to news reports and

interviews.

 

Some sleep experts interviewed said the side effect is increasingly

familiar to academic and research sleep specialists. But many

mainstream sleep clinicians see no problems with the drug,

interviews showed. No expert interviewed said he or she had stopped

prescribing Ambien due to fear of side effects.

 

Helene Emsellem, medical director of the Center for Sleep and Wake

Disorders in Chevy Chase, says she has seen no link between Ambien

and sleepwalking in her practice, which is one of the largest of its

type in the region. " Nor do we see [Ambien] standing out as

problematic " among other available sleep medications, she said.

 

Partial Arousal

 

 

 

---

-----------

 

 

Somnambulism, the clinical term for sleepwalking, is a " partial

arousal " disorder, in which a person is not fully asleep but not

completely awake.

 

In addition to medications, sleepwalking can be triggered by sleep

deprivation, alcohol, fevers, stress, and some mental and

neurological conditions.

 

Ambien may render some people unable to awaken completely even when

something significant disturbs their sleep, so they enter the state

of partial arousal, some experts say. " It is the case, perhaps, of

an unstoppable force meeting an immovable object, " said Michael

Sateia, chief of the Section of Sleep Medicine at Dartmouth-

Hitchcock Medical Center in Lebanon, N.H., and past president of the

American Academy of Sleep Medicine.

 

According to Stacia Sailer, medical director of the Sleep Disorders

Center at the University of Massachusetts, Amherst, some people

taking sleep medications (not just Ambien) can, in that partial

state of arousal, carry out many routine activities. The case of Lt.

Judith Renee Lasswell, 39, a Navy intelligence officer stationed in

Tampa, included several bizarre incidents, including a case of

alleged shoplifting that threatens her military career.

 

According to the complaint in the class-action suit, she once

wandered into the intelligence center where she works talking

incoherently, and her colleagues led her back to bed. She said she

has no memories of the episode.

 

But most damaging was an incident last September when, after taking

Ambien, Lasswell said she sleepwalked into the base exchange,

carrying several DVDs which she had purchased previously or rented

from the base library. After returning an " X-Files " DVD to receive

store credit, she was approached by base police, who claimed she had

taken the DVD off the shelf, failed to pay for it and returned it

for credit. She was handcuffed and charged with shoplifting DVDs and

a candle.

 

Lasswell said she has no memory of the incidents.

 

According to the complaint, Lasswell's top-secret security clearance

was subsequently revoked, and she faces larceny charges and a

dishonorable discharge. A 17-year Navy veteran, she risks losing her

pension and severance pay.

 

" I've never had a problem before in my life until I took Ambien, and

it's literally ruined my career and everything I ever worked for, "

Lasswell said in a statement. " I have gaps in memory from the whole

time I was on Ambien, which is very terrifying. "

 

In January, Lasswell requested a polygraph test to support her

defense in the military judicial process. According to the test

report, a copy of which was provided by Lask, Lasswell denied

intending to steal and falsely claiming store credit, and said she

did not remember the events related to the incident. The polygraph

examiner found " no deception " in her responses, according to the

report.

 

Difficult Data

 

 

 

---

-----------

 

 

There is no reliable estimate of how many Ambien users sleepwalk,

and no one knows who might be at risk. The prescribing information

for Ambien lists somnambulism as a " rare " side effect, meaning that

it has been reported in fewer than one in 1,000 patients.

 

Sateia says a lack of solid data on post-approval side effects makes

it impossible to know whether the company's estimation of the rate

is accurate.

 

After a drug is approved and marketed in the United States, the FDA

accepts (but does not actively solicit) reports of side effects from

doctors, patients and drug makers. FDA adverse event report

databases contain sleepwalking reports from 1997 through June 2005.

(Ambien has been available in the United States since 1993, but

sleepwalking events per se were not reported before 1997.)

 

There are 207 sleepwalking reports. Most of the incidents are

considered " idiopathic " by physicians reporting the episodes,

meaning their cause is not known. Of all sleep aids, however, Ambien

is linked to the most incidents -- 48 of them, or about a quarter of

the total.

 

The data contain two reports associated with Sonata, a drug that

acts in a way similar to Ambien. Sonata was approved in 1999. The

data contain no sleepwalking reports for Lunesta, the newest sleep

drug, which was not widely available until April 2005.

 

There are also fewer reports linked to older sleep aids called

benzodiazepines, including Ativan, Halcion, Restoril, Valium, and

Xanax. For these six drugs, which when considered as a group were

prescribed more times than Ambien, there are 18 reports collectively.

 

Larry Sasich, a pharmacist and consultant to Public Citizen, a

consumer advocacy group, says the adverse event reports " raise a

legitimate question " about a possible association between Ambien and

sleepwalking, particularly since " what winds up in the FDA's

database is only the tip of the iceberg. " Researchers believe that

only a small portion of adverse drug reactions are reported to the

FDA.

 

Adverse event data must be interpreted carefully because many things

affect what is reported and how often. Sleepwalking is particularly

tricky to track. It's not like liver failure, for example, which

unmistakably either happens or does not. Many people may never find

out about their sleepwalking or may not understand what they

experienced. Others are reluctant to report it: " People do not

volunteer this information, " Morgenthaler said. " If you do not ask

specifically about this behavior, you will miss most of it. "

 

The Mayo Clinic Sleep Center's standard patient questionnaire now

includes questions about sleep-related eating.

 

" In a sane world . . . [reports like those for Ambien] would be an

occasion for FDA to ask the manufacturers to do careful

surveillance, " said Jerry Avorn, chief of the Division of

Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's

Hospital, a Harvard Medical School affiliate. " But they're not going

to do that. "

 

Meanwhile, Sanofi has introduced a new formulation of Ambien, called

Ambien CR, designed to sustain sleep throughout the night. Sonata

and Lunesta are spending hundreds of millions of dollars on

advertising to battle for market share, and competing drugs are

working their way toward approval. Consumers are being sold on the

benefits and safety of sleep medications as never before.

 

" That can give patients, and physicians for that matter, the

impression that the management of [sleep] problems is as simple as

giving someone a prescription for a sleeping medication and sending

them on their way, " Sateia said. " It's not that simple. " ·

 

Martin F. Downs is a freelancer in Meriden, N.H. Join Michael Sateia

of the Dartmouth-Hitchcock Medical Center today at 1 p.m. for a Live

Online chat on sleep disorders and reported Ambien side effects at

www.washingtonpost.com. Comments: health.

 

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