A record 43 million prescriptions for
sleep pills were written by U.S. physicians in 2005, and by 2010 it has
been estimated that the drug industry will take in at least $5 billion
annually from these sales.
The number of adults aged
20 to 44 using sleeping pills doubled from 2000 to 2004, and
the number of kids ages 1-19 who take prescription sleep
remedies jumped 85% during the same period.
Changing regulators'
attitudes toward sleep aids won't be the only hurdle for the
makers of these new products. They'll also have to convince
insomniacs that there's nothing wrong with taking sleeping
pills. To that end, Sepracor and Neurocrine -- along with
its Big Pharma partner, Pfizer Inc. (PFE ) -- are gearing up
for major direct-to-consumer advertising blitzes. The
strategy worked for Sanofi. When it pumped $55 million into
U.S. print and TV ads for Ambien in 2002, annual sales of
the drug jumped to $1.5 billion, nearly twice the level in
2000.
The scenario of whole
societies popping insomnia and wake-up pills as if they were
aspirin raises disturbing questions. Are drug makers so
intent on seeding an insomnia market that they have grown
insensitive to the hype their marketing campaigns may fuel?
And what about the long-term impact of messing with the
brain's natural sleep processes? Unknown. Until drug
companies
can point to long-term safety data, physicians, patients,
and regulators can be forgiven for having some reservations.
Click the links below for detailed information by class of
sleeping pills:
More over-the-counter
sleep aids are purchased than any other OTC drug, and 25% of
Americans take some type of medication every year to help
them sleep. Popular OTC brands include Benadryl, Nytol,
Sominex, Tylenol PM, Advil PM and Nyquil. Their main
ingredient is an antihistamine named diphenhydramine and in
some case (Nyquil), alcohol.
Historically, sleep aids
have been linked with addiction, depression, and suicide.
Even though newer drugs are designed to avoid such troubles,
many physicians and insomniacs are frightened that there
will be unforeseen complications.
FDA advises people who are treated with
any of these products to take the following precautions:
Talk to your health care provider before you start
these medications and if you have any questions or
concerns.
Read the Medication Guide, when available, before
taking the product.
Do not increase the dose prescribed by your health
care provider. Complex sleep-related behaviors are more
likely to occur with higher than appropriate doses.
Do not drink alcohol or take other drugs that depress
the nervous system.
Do not discontinue the use of these medications
without first talking to your health care provider.
New Sleeping Pills on The Horizon?
Glaxo and Actelion Ltd. strike deal to develop new insomnia
drug...
A new experimental sleeping pill called
Almorexant is in development, and Glaxo is betting at
least $146 million that it will be a blockbuster with annual
sales of more than $1 billion.
Almorexant is a new kind of drug that
temporarily reduces levels of the brain chemical orexin,
which is thought to help keep people awake. Sleep experts
say that the drug needs further study but may offer some
benefits over Ambien (Sanofi-Aventis), including fewer side
effects. If things go smoothly for Glaxo,
Almorexant could make it to the American
market by 2011.
The pipeline for sleeping pills recently
suffered two big setbacks.
In December, the Food and Drug Administration
tossed a wrench at Neurocrine Biosciences' experimental
anti-insomnia drug Indiplon, requiring the biotech to do
further time-consuming and expensive tests. Neurocrine's one
time partner, Pfizer, had earlier backed out of a marketing
deal, given Indiplon's difficulty getting approved.
Neurocrine is in talks with the FDA to resolve its issues.
In March of 2007, Merck and its Danish
partner Lundbeck, dropped the experimental sleeping drug
gaboxadol because of safety concerns. The drugmakers threw
in the towel not long after the FDA announced a safety
warning for the entire class of anti-insomnia drugs, based
on reprots of patients sleep-driving, sleep-eating, and
sleep-sex while under the influence of these drugs - with no
memory of the actions afterward. The FDA also warned of
allergic reactions and facial swelling.
These warnings apply to all the sleeping
drugs that are currently on the market, including Ambien and
Sanofi-Aventis, Sepracor's Lunesta, Sonata from King
Pharmaceuticals and Takeda Pharmaceuticals' Rozerem. All
these drugs, except for Rozerem, are addictive and work by
sedating the patient. Rozerem works by controlling the
internal sleep-wake cycle.
Source: SleepWeb (Marketdata Enterprises, Inc.) research
