Sleep for Sale

Get ready for the next big pharma ad blitz.

Sleep is about to become big business. Once on the fringes of scientific respectability, human sleeping habits are now intensely scrutinized by top academic researchers, who warn that 24/7 lifestyles have turned Americans into frazzled, irritable sleep cheats who are a menace on the highways, more prone to diseases, and likely to live shorter lives. But now, if you believe the drug marketers and their upcoming ads, help is at hand, in the form of new pills that will deliver a refreshing night’s sleep with no morning-after hangovers. Three major new prescription sleep aids are slated to make their debuts in the next year: Estorra, Ramelteon, and Indiplon, the last of which is licensed by Pfizer, the world’s largest drug company. As competition for the multibillion-dollar “sleep market” heats up and companies saturate the airwaves with commercials, the demand for sleeping pills is expected to explode.

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So will these new elixirs genuinely relieve a major health problem? Or is big pharma hyping a minor concern to create a market for the treatment? Many members of the medical establishment worry that sleep drugs could be the next antidepressants -- moderately useful drugs turned into blockbusters by aggressive marketing. “The sinister purpose of these ads is to convince people they have ailments they didn’t know they had -- like a medical condition called ‘insomnia’ that needs a chemical treatment,” says Dr. Jerry Avorn, a drug expert at the Harvard Medical School in Boston and the author of Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs.

Nor are all medical professionals convinced that less sleep equals more disease: “If you have kids,” says Dr. Jerome M. Siegel, a sleep expert and professor of psychiatry at UCLA, “you go down to six hours of sleep a night and stay there for the next 10 years, but I haven’t heard any evidence that parents live shorter lives or have more illnesses than others.”

In general, the data that companies are using to tout the new pills is problematic. While it’s common practice for the industry to fund drug tests at academic institutions, usually the corporate-funded research is balanced by at least some government-supported studies. But there’s almost no public funding for studying sleeping pills, says Dr. Daniel F. Kripke, a psychiatrist and sleep researcher at the University of California at San Diego -- which means that information about these drugs comes almost solely from company-sponsored research. “If the drug companies are helping them send their kids to college,” says Kripke, “scientists aren’t likely to criticize the product.”

And far from “a significant change in the landscape” of sleep medications, in the words of one corporate-funded researcher, the new drugs’ actual benefits are quite modest. After six months of treatment, patients taking Estorra took 30 minutes to fall asleep, compared to 45 minutes for the group taking a placebo.

Patients on the drug slept about 30 minutes longer every night and awakened 1.6 times per night, versus 2 times for those on the dummy pills. In fact, there’s not much new about either Estorra or Indiplon, although Sepracor, which makes Estorra, boasts that its pills are longer-acting. Both are “copycat” drugs in the same chemical class as the already popular sleep aid Ambien.

Nevertheless, says Avorn, “there’s a huge financial incentive for drug companies to turn on the volume full blast.” With few breakthroughs in the pipeline and several blockbusters -- the cholesterol medication Zocor and the antidepressant Paxil, for instance -- about to lose their patent protection, big pharmaceutical companies are desperate for new revenue streams. Compared with the $11 billion spent yearly on antidepressants, according to the pharmaceutical consulting firm IMS Health, the $1.7 billion sleeping-pill market is virtually virgin territory. Sleep researchers say that between 10 and 15 percent of Americans experience serious insomnia (defined as not getting a good night’s sleep for a month or more), but only 8 percent take prescription drugs. And the industry’s potential pool of customers is far larger than that: According to surveys by the National Sleep Foundation, which is partly funded by pharmaceutical companies, 37 million seniors suffer from frequent sleeplessness, and a full 51 percent of Americans report occasional restless nights. It’s easy to see why Sepracor predicts sleeping-pill sales will surge past the $5 billion mark by 2010.

And why that company, based in Marlborough, Massachusetts, is gearing up for a promotional extravaganza: Sepracor has recruited marquee professors at major universities to test the drug and then extol its virtues at conferences for doctors -- such as psychiatrists and gerontologists -- most likely to write prescriptions for sleep aids; it has earmarked millions for spending on advertising; and it has tripled its sales force, from 400 to 1,250. As CFO David Southwell told the Wall Street Journal, sleep is “like depression before Prozac.”