Janet Makinen, a Florida housewife, was prescribed Ambien in 1998
for insomnia. About two weeks later, she began walking in her sleep
to her kitchen and devouring food.
It didn't matter what kind of food, either. Makinen, 55, of Dade
City, Fla., wolfed down raw eggs, uncooked rice, cans of vegetables,
loaves of bread, and bags of chips and candy.
An hour after her binge-eating, she'd wake up vomiting.
Makinen gained so much weight from the nocturnal feedings that
she ballooned from a size 1 to a size 12. She still suffers from
stomach problems, including an ulcer.
She stopped taking Ambien in 2005. And now she's suing
Sanofi-Aventis, the manufacturer of the popular prescription
sleeping medication.
A class-action suit filed March 6 in U.S. District Court in the
Southern District of New York claims that Ambien caused Makinen and
hundreds of other users to enter into trance-like states in which
they drove cars, binged on food and engaged in other activities they
have no memory of.
The suit accuses Sanofi-Aventis of inadequately warning users of
the dangers of amnesic sleep-eating, sleepwalking and sleep-driving.
Ambien was introduced to the market in 1993, but its sales have
soared in the past few years - due mainly to an intensive consumer
advertising campaign.
Last year, an estimated 26.5 million prescriptions were dispensed
for Ambien - more than double the number written in 2001 - making it
the nation's best-selling prescription sleeping pill.
And the strange behavior that some users exhibit in their
sleepwalking states occasionally even lands them in jail - much to
their surprise, since amnesia is another documented side effect.
Kathleen Callahan, a New York lab technician who claims there
were mornings when she found her refrigerator door open, crumbs on
the floor, chocolate icing on her hands and a ring of chocolate
around her mouth. One morning she woke up in bed with her hands in a
potato chip box.
Callahan also alleges she was twice sexually assaulted by a
neighbor while in a sleepwalking state.
One New York pharmaceutical defense lawyer specializing in class
actions, who asked not to be named, said he thinks it is unlikely
the New York case will proceed as a class action, because physicians
receive information about a medication from many different sources
and it could be difficult to isolate the communications physicians
had with the manufacturer.
Following the recent news reports, Sanofi-Aventis issued a
statement saying that sleepwalking occurs in about 4 percent of the
adult population, and that while "events of sleepwalking have
occurred during treatment with Ambien, these instances cannot be
systemically linked to the product."
It also said that a recent company analysis concluded that the
current prescribing information is accurate: "Somnambulism is a
possible rare adverse event."
The manufacturer also reminded users that Ambien should only be
taken when the user can have eight hours of uninterrupted sleep, and
that it should never be taken with alcohol.
The Food and Drug Administration says the drug's current warnings
are adequate.
David Benjamin, a toxicologist in Newton, Mass., said that while
the strange side effects of Ambien are very believable, a product
liability suit against the manufacturer faces an uphill challenge.
"The warnings say take the drug while you're in bed, and don't
take it while you're driving," he noted.
That could make it difficult to prove a "failure to warn" claim,
according to Benjamin.
The New York pharmaceutical defense lawyer suggested that
Sanofi-Aventis' possible liability for its warnings about the risk
of sleepwalking may hinge on whether the company had documented the
risk of Ambien-caused sleepwalking, and withheld it from physicians
and consumers.
Benjamin also said that Ambien-impaired individuals arrested for
criminal behavior could argue a "lack of intent," claiming they had
no intent to drive a car or engage in illegal activity.
On The Road Again
Attorneys who specialize in drunk-driving cases are already
running into Ambien cases.
William Head, an attorney in Atlanta who specializes in DUI
defense, has defended several drivers who landed in jail after
sleep-driving episodes.
"You're seeing people with not one blemish on their driving
history suddenly charged with a series of ridiculous driving
situations," he said. "They don't know they're driving."
Head recently defended a man in Decatur, Ga., who had several
drinks and took two Ambien. The last thing he remembers is watching
David Letterman on television. He was arrested on multiple driving
charges, including driving on the wrong side of the road. But a
judge was unconvinced that Ambien was the cause of the man's bizarre
behavior, since he had also consumed alcohol. As a result, Head's
client was convicted of driving under the influence.
In a new case, Head is representing a Florida businessman who
took Ambien but hadn't consumed any alcohol or other medications.
When Fulton County, Ga. police pulled him over for erratic driving,
the man's pants were down around his ankles.
"He took it [Ambien] in the morning," Head said. "The next thing,
he's driving in the broad daylight with his pants down."
Head said he plans on arguing the case before a jury, which he
hopes to educate about the risk of sleep-driving while using Ambien.
"The key to me in these cases is if the person taking the
medication had no prior episodes of sleepwalking or sleep-driving,
then that's a very good case," Head said. "Because [Ambien's]
packaging materials in no way indicate the symptoms of getting
behind the wheel and not knowing you're there."
There has also been at least one Ambien-related airline arrest.
Sean Joyce, a British painting contractor, was on a flight from
Charlotte, N.C. to London last July. He had taken an Ambien pill and
drunk several glasses of wine when he got up, grabbed a young woman
sitting next to him, started yelling and ripped his shirt off.
Joyce reportedly threatened to kill himself and everyone on the
plane. He was handcuffed and the plane was diverted to Boston
"He woke up in a jail cell in East Boston with absolutely no
memory of what happened," said Michael C. Andrews, an attorney in
Boston who defended Joyce.
Andrews convinced federal authorities that Joyce's aggressive
behavior and amnesia were caused by Ambien.
Under a plea agreement, Joyce was sentenced to the five days he
had already served.
Twilight Zone
Benjamin, the Massachusetts toxicologist, likened the bizarre
effects of Ambien in certain individuals to those of
benzodiazepines, such as Halcion and Xanax.
"Somehow, they affect the brain adversely and people have this
dissociative reaction where they do weird things that they don't
remember," he said.
"We've known about these types of effects for date-rape drugs,"
he said. "This is a very, very similar reaction."
Ambien is classified as a non-benzodiazepine hypnotic.
William R. Johnson, a chemist at the Wisconsin State Laboratory
of Hygiene, who studied Ambien-impaired drivers in Wisconsin over a
six-year period, said it's not clear why Ambien causes sleepwalking
in some users. But he theorized that they may partially awaken after
four or five hours of sleep.
"When you get beyond that four-hour period, in some people the
medication loses some of its effect and it allows them to become
semi-awake, but not conscious," he said.
Sanofi-Aventis has recently released a timed-release sleeping
pill, AmbienCR, aimed at maintaining a full eight hours of sleep.
Life In The Slow Lane
Many states don't test for Ambien when making impaired-driving
arrests. But in some state toxicology labs, Ambien is among the top
10 drugs found in impaired drivers.
The Wisconsin study identified Ambien in the bloodstreams of 187
drivers arrested from 1999 through 2004. More than half of the
Ambien-impaired drivers also tested positive for alcohol, and nearly
half tested positive for other drugs, including benzodiazepines such
as Valium, Xanax and Klonopin.
In 21 cases where Ambien was the only drug found, driving
behavior ranged from hitting light poles to running over curbs to
driving in the wrong lane.
The main characteristic of Ambien-impaired drivers was that they
drove well below the speed limit and kept driving until they hit
something, according to Johnson.
"The slow speed was very common, and essentially driving until
you couldn't drive anymore. They tended to run into a stationary
object, like a light pole or parked car," he said.
In five cases in which no alcohol or other drugs were found,
Johnson said, police reported that the Ambien-impaired drivers
shared the same zombie-like characteristics.
"They seemed very much disoriented; their eyes wouldn't focus on
individuals," he said. "They would just look right through a
person."
Questions or comments can be directed to the writer at: nora.tooher@lawyersweekly.com