Insomnia: Drug Makers See ‘Huge, Numbers’
Jan. 30–The impending rollout of a new medicine for long-term treatment of insomnia has the potential to make its manufacturer millions — and to further acceptance of the sleeping pill, traditionally a dark character in the prescription drug world.
Some sleep-disorder specialists are hailing the new drug. But others caution that chronic use of sleeping pills is ill-advised.
Lunesta, made by Sepracor of Marlborough, Mass., is the first insomnia drug approved by the federal Food and Drug Administration for long-term use. With similar drugs, including market leader Ambien, the FDA advises treatment should last no more than 10 days, although a doctor can prescribe longer.
“Night after night after night” is Sepracor’s slogan for the new drug.
Years in development, Lunesta was proved relatively free of side effects in clinical trials that lasted six months — the longest for any sleep aid. The drug will be priced to compete with Ambien, which accounts for about 75 percent of the $2-billion U.S. insomnia drug market. According to Merrill Lynch, Sepracor will sell Lunesta at a wholesale price of $3.70 a pill, about 10 percent more than a similar dose of Ambien.
Once it receives what is expected to be routine approval from the Drug Enforcement Administration, likely within a few weeks, Sepracor will launch Lunesta with a marketing campaign this year costing at least $100 million — of which more than $60 million will be advertisements targeted to sleepless consumers. Chances are good that if you’re wide awake at 3 a.m. with the television on, you’ll see a Lunesta ad.
Health-care professionals also will find Lunesta hard to miss: more than 1,200 salespeople, according to Sepracor, will be paying calls on doctors, pharmacists, insurers and others.
“These aren’t green troops we’re putting out there,” Dr. Mark H.N. Corrigan, Sepracor’s head of research and development, said in a conference call with analysts last month when the FDA gave Lunesta final approval.
Sepracor, a roughly $375-million company that made no money last year, predicts that sales of Lunesta eventually will top $1 billion, which would make it one of the best-selling drugs in the world. Analysts predict slightly lower sales, but nonetheless maintain that Lunesta will turn the Massachusetts firm into a highly profitable company. They recommend buying the stock. Sepracor shares a year ago sold for less than $30, but jumped to $61.86 in the wake of FDA approval. They closed the week at $56.58, up 25.5 cents for the week.
“They’ve got a good competitive entry into a rapidly growing market and that’s generally a recipe for success in the pharmaceutical industry,” said Robert Hazlett, an analyst with SunTrust Robinson Humphrey.
Continued success, however, will not come without a fight.
Pfizer, the world’s largest pharmaceutical firm, will start selling a new sleeping pill late this year or early next if it wins FDA approval, as expected. The makers of Ambien are awaiting FDA approval of a new, longer-lasting version. So is King Pharmaceuticals, which sells Sonata. And a Japanese company, Takeda, hopes to sell a sleep aid in America.
Consumers: Prepare for an insomnia war that could rival the erectile-dysfunction ad campaign that is all over TV.
Sleeping pills have been around for decades.
An early version was the barbiturates, a class of tranquilizers, which today are prescribed for a few ailments, including seizure disorders and, occasionally still, insomnia. Seconal is a barbiturate. But barbiturates are prone to abuse, their side effects can be severe, and just a small number of the pills can kill. Marilyn Monroe and Jimi Hendrix died of barbiturate overdoses, which did little to enhance the drug’s reputation as safe.
Nor did the Rolling Stones’ 1966 hit song about barbiturates, “Mother’s Little Helper,” which mocked a woman who took a little yellow pill, warning:
If you take more of those
You will get an overdose,
No more running for the shelter
Of a mother’s little helper
The next class was the benzodiazapenes: drugs such as Valium and Xanax, which are also prescribed for anxiety, panic disorder, and other conditions. But benzodiazapenes can be addictive, and the body builds tolerance, meaning more and more must be taken to achieve the same result. They can also impair memory and leave a person groggy or disoriented the next morning.
“They put people to sleep but they had a lot of side effects and other issues,” said Gary A. Lyons, president and CEO of Neurocrine Biosciences, which has developed the new sleep aid that Pfizer will sell. This experience with benzodiazepenes, Lyons said, prompted most large pharmaceutical firms to “just give up” on developing sleep medications.
Ambien, introduced in the United States in 1993, was the first of a new category of sleep aids known as nonbenzodiazapine hypnotics, which act differently on the brain. Manufactured by Sanofi-Synthelabo, a U.S. affiliate of a French company, Ambien has relatively few side effects and is nonaddictive. As sales grew, other drug firms began to pay attention.
The sleeping pill stigma was weakening.
Ambien sales have grown at an annual rate of about 20 percent recently. More than 25 million prescriptions were dispensed last year, making it the 12th-most-commonly prescribed drug in the United States.
“Ambien is the workhorse,” says Dr. Richard P. Millman, director of the Sleep Disorder Center of Lifespan hospitals and a professor at Brown University Medical School.
Untreated, insomnia can be a scourge. “I’ve had patients pray to God to go to sleep,” Millman says.
Millman defines insomnia as “the inability to fall asleep initially, the inability to fall back asleep in the middle of the night, or a feeling that you’re just not getting a restorative sleep.” The daytime result is fatigue, tiredness, or memory or concentration problems.
According to Millman, numerous studies have shown that some 12 percent of the adult American population suffers from chronic insomnia — the inability to sleep several times a week. Intermittent insomnia, says Millman, affects up to 30 percent of adults in this country.
“We’re talking millions and millions of people,” Millman says. “It’s just huge, huge numbers.”
Insomnia takes a toll on more than its sufferers. According to the National Sleep Foundation, sleep deprivation and sleep disorders cost Americans more than $100 billion a year in medical expenses, sick leave, lost productivity, and property damage — car accidents caused by lack of sleep, for example.
Insomnia is not itself a disease but a symptom of something else, Millman says. Alcohol and drug abuse can cause it, as can anxiety and depression. Chronic pain can be at fault, and also the consumption of too much caffeine, nicotine, or fluids before bed. And there are other causes, including a disorder known as “restless leg syndrome” and disturbances in the body’s circadian rhythms that night workers may experience.
Depending on cause, Millman uses different therapies, including behavior modification, to treat insomnia. But unlike some sleep specialists, who remain wary of prescription sleep aids, he will sometimes prescribe Ambien or Sonata. One instance is when a patient comes to him with a sudden case of insomnia. “If you can break it quickly,” he says, “perhaps that will be the end of it.”
Millman also has patients for whom he has prescribed Ambien for years, and he welcomes the introduction of Lunesta.
“Now the argument that this class of sleeping pills can’t be used long-term falls apart,” he says. “You don’t build up tolerance, you don’t get addicted to it — you can ‘cold-turkey’ and you just won’t sleep.”
And while it belongs to the same class of drugs as Ambien and Sonata, Lunesta may work for patients who do not respond to them, Millman says.
“No drug works on everybody.”
Not every sleep professional believes that extended use of prescription sleep drugs is wise.
“Sleeping pills put a ‘Band-Aid’ on sleeping issues,” says Los Angeles-based therapist Nancy B. Irwin.
“Certainly, under extreme conditions — trauma, emotional upheaval — they serve a purpose for the short-term, but over the long-term, your body begins to rely on them and cannot enter the sleep state without them. It is natural to sleep. If you are having difficulty sleeping, you have some unresolved emotional issue or need lifestyle adjustments.”
Irwin offers many treatments for insomnia, but for a simple case, she advises: “Allow your body and mind to naturally shut down and treat yourself like you would a baby. Would you tell your child, right before bedtime, about the tsunami death toll? Or a rapist on the loose? Feed your subconscious with positive, nurturing thoughts right before bedtime and you will sleep much better.”
Says Cassandra Juarez, a counselor in Illinois: “While I don’t oppose the use of sleeping pills outright, I think it should be a last resort. Before prescribing sleep aids, emotional problems should be ruled out or addressed through therapy. Otherwise, you are treating the symptoms and not the underlying problem.”
Even a consultant for King Pharmaceuticals, which sells Sonata, raises a caution about long-term use of sleep aids. While it may be appropriate for some patients, says Dr. Stephen James, a sleep specialist for 20 years, there is a danger that doctors will prescribe a drug and then not follow up.
“The downside as I see it is that [some] doctors will overprescribe and patients will be on the medication for long periods of time without reevaluation,” says James, of San Diego. That, he says, could result in a doctor failing to diagnose and treat an underlying condition.
In Sepracor’s conference call last month, Chairman of the Board and Chief Executive Officer Timothy J. Barberich described insomnia as “one of the most prevalent and growing medical needs in our society.”
W. James O’Shea, president and chief operating officer, said predictions that Lunestra would generate $1 billion could well be “pessimistic.” O’Shea also said the company’s $60-million media budget is about equal to what McDonalds spends every three months.
For most if not all of this year, Ambien will be Lunesta’s only major competitor. A spokesman for Ambien’s manufacturer said the company takes the new drug seriously, and implied that advertising for Ambien will be boosted. She provided no details, however, saying only that consumer ads would be “commensurate to Ambien’s position in the marketplace.”
The real war will begin in about a year, when Pfizer launches Indiplon, developed by San Diego-based Neurocrine Biosciences. An acknowledged master of marketing, Pfizer — maker of Lipitor, Viagra and other top-selling drugs — is expected to launch a campaign rivaling or exceeding Sepracor’s.
“They view it as a potential blockbuster,” says Lyons, Neurocrine’s chief. “We’re very excited.”
Coming soon after Indiplon will be new, longer-acting versions of Ambien and Sonata. And at some point, Osaka, Japan-based Takeda is likely to win FDA approval for its Ramelteon, which is a new class of sleep aid that the company claims induces “what is very similar to natural sleep.”
If all of these drugs reach the market, sales of sleep aids could more than double in the next few years, analysts say.
“In general, a lot more prescriptions will be filled for these types of agents,” says analyst Hazlett. “It will be a competitive marketplace.”
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