Sales of Sleeping Pills Are Causing Worries
By STEPHANIE SAUL
New York Times
February 07. 2006
Americans are taking sleeping
pills like never before, fueled by frenetic workdays that do
not go gently into a great night's sleep, and lulled by a
surge of consumer advertising that promises safe slumber
with minimal side effects.
About 42 million sleeping pill
prescriptions were filled last year, according to the
research company IMS Health, up nearly 60 percent since
But some experts worry that the
drugs are being oversubscribed without enough regard to
known, if rare, side effects or the implications of
long-term use. And they fear doctors may be ignoring other
conditions, like depression, that might be the cause of
Although the newer drugs are
not believed to carry the same risk of dependence as older
ones like barbiturates, some researchers have reported what
is called the "next day" effect, a continued sleepiness
hours after awakening from a drug-induced slumber.
Ten percent of Americans report
that they regularly struggle to fall asleep or to stay
asleep throughout the night. And more and more are turning
to a new generation of sleep aids like Ambien, the best
seller, and its competitor, Lunesta. Experts acknowledge
that insomnia has become a cultural benchmark a side effect
of an overworked, overwrought society.
"Clearly, there's a significant
increase in people who report insomnia and, from my
perspective, that is the result of our modern-day
lifestyle," said Dr. Gregg D. Jacobs, a psychologist and
assistant professor of psychiatry at Harvard. Or at least
that is an impression that drug makers are clearly trying to
capitalize on, he said.
And that concerns him and some
other researchers who warn that despite their advertised
safety, the new generation of sleep aids can sometimes cause
strange side effects.
The reported problems include
sleepwalking and short-term amnesia. Steven Wells, a lawyer
in Buffalo, said he started using Ambien last year because
his racing mind kept him awake at night. But he quit after
only one month, concerned about several episodes in which he
woke up to find he had messily raided the refrigerator and,
finally, an incident in which he tore a towel rack out of a
"The weird thing was that I had
no recollection of it the next day," said Mr. Wells, who
added that he found the episodes frightening.
Ambien's maker, Sanofi-Aventis,
said the drug had been used for 12 billion nights of patient
therapy. "When Ambien is taken as prescribed, it's a safe
and effective treatment," said Emmy Tsui, a company
A Food and Drug Administration
spokeswoman, Susan Cruzan, said she was not aware of an
unusual number of complaints with the drugs.
Drug makers spent $298 million
in the first 11 months of 2005 to convince consumers that
the sleep aids are safe and effective. That was more than
four times such ad spending in all of 2004.
In the last year, much of the
advertising surge has been a result of competition from
Lunesta, which the drug maker Sepracor introduced last April
to compete with Ambien. Through November, Sepracor led the
sleeping pill advertising field, spending more than $185
million, according to figures from TNS Media Intelligence,
which did not have final figures for December.
In response, Sanofi-Aventis,
marketing both Ambien and its controlled-release version,
Ambien CR, spent $107 million from last January through
November, according to TNS. That was nearly double its ad
spending on Ambien in 2004.
Even the most infrequent
television viewers would have trouble missing the Lunesta
ads, which feature a luna moth fluttering around the bed of
a peaceful sleeper. Dr. Jacobs said that in one hour of
prime-time television recently, he saw three ads for
sleeping pills: two for Lunesta and another for Ambien.
"You've got the patient
population being bombarded with advertising on TV," Dr.
Jacobs said. "You've got increased advertising to
physicians. You've got a formula for sales going up
One financial analyst, Jon
LeCroy of Natexis Bleichroeder, said Lunesta's ad campaign
last fall was tied to the new season of "Desperate
Housewives," whose audience is about 55 percent female.
Studies have shown that women have insomnia more frequently
Last week, Sepracor's stock
jumped $8.53 in one day, after Sepracor reported a profit
and remarkably strong use of Lunesta in its first year on
the market, with sales of $329 million. More than 213,000
doctors wrote 3.3 million prescriptions for it last year,
the company says.
Sepracor announced the addition
of 450 people to its current sales force of 1,500 to
increase marketing of the drug to physicians.
Sanofi-Aventis, with a sales
force of 3,000, is working to shift patients from Ambien,
which loses its patent protection in October, to the newer
version, Ambien CR. The newer pill has a quickly dissolving
outer layer meant to immediately induce sleep, with a
slower-dissolving inner layer to sustain sleep.
Another drug in the class is
Sonata, marketed by King Pharmaceuticals. Because it is
short acting, Sonata is recommended for people who have
trouble falling asleep but no trouble staying asleep.
Drugs in the class are
frequently referred to as "Z" drugs, a play on both their
effect and the Z's in their generic names, like zolpidem (Ambien)
and eszopiclone (Lunesta). All aim at a brain
neurotransmitter that is believed to reduce neural activity.
Another new entrant to the
market, Rozerem, by the Japanese company Takeda
Pharmaceuticals, has been available in drugstores since
September but has not yet been heavily advertised. The drug
works by a different mechanism from the others, acting on
the brain's melatonin receptors, which are believed to play
a role in sleep-wake cycles.
Mr. LeCroy, the analyst, who is
also a medical doctor, predicts the advertising will
intensify if Neurocrine Biosciences and its partner Pfizer
are permitted to introduce their new sleeping pill, Indiplon;
an F.D.A. decision on that is expected in May.
"That's going to make the
competition get more cutthroat," Mr. LeCroy said, predicting
that the market for branded sleeping pills, currently about
$2 billion a year, could grow to $3.8 billion, even with
Ambien set to go generic. "This is only going to get
The Carlat Psychiatry Report, a
newsletter by Dr. Daniel J. Carlat, a psychiatrist in
Newburyport, Mass., reviewed the Z drugs recently and
concluded that their differences were merely subtle. But Dr.
Carlat warned that Lunesta, because it was longer acting,
was more likely to cause next-day sleepiness problems "in
comparison with some of its cousins."
Dr. Carlat cited a 1998 study
in Britain, published in The Lancet, which found that taking
zopiclone, the compound known as the "mother" of Lunesta and
marketed in Europe, was linked to an increased risk of
But Sepracor's chief financial
officer, David P. Southwell, said that Lunesta, while a
chemical variant of zopiclone, was a totally different drug.
He referred a reporter to the F.D.A.-approved label, which
lists clinical studies of next-day effects showing there was
no consistent pattern of impaired mental functioning the day
after Lunesta use.
The possible role of Ambien was
investigated in connection with well-chronicled
transportation disasters in 2003 the crash of the Staten
Island Ferry, which killed 11 passengers, and an accident
involving a Texas church bus in Tallulah, La., which killed
8 passengers. The assistant captain who was piloting the
ferry, like the bus driver, had a prescription for Ambien,
but there was no evidence either had taken it before the
Dr. David G. Fassler, a
clinical professor of psychiatry at the University of
Vermont College of Medicine, said he was concerned that the
heavy marketing and prescribing of the sleep medications
would lead to use in patients who have underlying conditions
that are left untreated.
"I'm concerned that difficulty
sleeping can be a sign of multiple disorders, including
problems with anxiety and depression," he said, expressing
worry that patients who are not thoroughly evaluated might
be treated for their insomnia while other problems, like
anxiety or decreased appetite, are not addressed.
In clinical trials, the most
common side effect of the drugs, however, is that people
wake up feeling sleepy the next day.
Dr. Daniel J. Buysse, a
University of Pittsburgh psychiatrist who has consulted for
the industry on sleeping pills, said they were a rare
example of drugs in which the desired effect and the major
side effect were the same thing. "One occurs when you want
it, and the other occurs when you don't," he said.
Another problem associated with
using sleeping pills is a condition commonly called
traveler's amnesia, in reference to the frequent use by
people who travel across time zones. Such amnesia can occur
when people return to daytime activities too quickly after
taking the drugs.
The labels carry warnings that
the drugs should be used only when people can devote a full
night to sleeping. In some cases, however, users have
reported that they awakened during the middle of the night
in sleepwalking states, but like Mr. Wells, the lawyer in
Buffalo had no recollection of their activities.
The amnesiac effects of Ambien
were a factor in the acquittal last week of a United States
Air Force linguist who had been charged with raping a
colleague while the two were stationed in Qatar. The woman
who said she was the victim, also a linguist, testified that
she was not sure whether the incident was a dream because
she had taken Ambien, according to the Stars and Stripes
report on the military trial, which occurred in Britain.
Dr. Buysse said such bouts of
nocturnal uncertainty occur occasionally with various Z
"There have been some case
reports of people who have been sleepwalking only when
taking the drug," Dr. Buysse said. "I think it's rare, and
it's the kind of thing that no one is going to have a very
good estimate of. But if it happens to you, who cares if
you're the only person of many?"