Get ready for the sleeping-pill smackdown. Over the next few weeks, the drug company Sepracor will roll out a $60 million marketing campaign for its new sleep aid, Lunesta, which was recently approved by the FDA. Sanofi-Aventis, whose blockbuster sleeping pill, Ambien, is currently the market leader, will respond with a new product of its own: a continuous-release form of Ambien for people who wake up in the middle of the night and have difficulty falling asleep again (as opposed to those who can't fall asleep in the first place). New sleeping pills are also on the way from Pfizer and Japanese drug maker Takeda.
Liberal docs who have taken to savaging big pharma—including Marcia Angell, Jerome Kassirer, and John Abramson in recent books—argue that these companies now do little but marketing, aggressively promoting drugs that are expensive, potentially unnecessary, and at times dangerous (consider the ongoing flap over Merck's painkiller, Vioxx). Pharma ads often whip up demand for pricey drugs, sometimes by convincing people they are sicker than they are so that they'll hound their doctors for pills they probably don't need. The biggest problem with the sleeping-pill campaigns, though, isn't that they hype a minor problem or tout a risky remedy. It's that they threaten to point people away from what's emerging as a better remedy for the sleep-deprived.
Insomnia is not a trumped-up problem invented by nefarious marketing wizards. The National Sleep Foundation's 2002 Sleep in America poll suggests that 35 percent of adult Americans experience at least one symptom of insomnia every night or close to it. (More conservative estimates place the figure for the chronically sleepless at between 10 percent and 20 percent.) Poor sleep is associated with a host of other problems, including obesity, diabetes, heart disease, and depression. And it has a profound effect on quality of life: A recent study by Princeton psychologist Daniel Kahneman found that number of hours of sleep influenced people's daily happiness more than a range of other factors, including how much money they made. What's more, only a small fraction of the bleary-eyed currently seek treatment. So, to the extent that manically cheery actors can induce people to address their sleeplessness, rather than dragging themselves out of bed to soldier miserably through the day, pharma ads may be a useful wake-up call.
There's also something to be said for the current wares. Sleeping pills are getting better: Lunesta, Ambien, and a similar drug called Sonata cause fewer side effects than their predecessors—less grogginess and bumbling around the next morning. Even better, they aren't nearly as addictive. A recent clinical trial—sponsored by Sepracor but published in the reputable professional journal Sleep—found that patients who took Lunesta every night for six months didn't need to up their dosage because they didn't become tolerant. This finding helped convince the FDA to approve Lunesta for long-term use, and it probably holds for Ambien and Sonata as well.
So why not welcome the coming wave of sleeping-pill ads as a kind of public service campaign? The problem is that while pills can be the treatment of choice for intermittent insomniacs—those who have a bad night now and then—when it comes to the people who truly can't sleep, drugs probably aren't the best option.
A growing number of sleep experts now think that serious insomniacs don't need a lifetime of pills. They need therapy—cognitive-behavioral therapy, which in this context refers to a group of techniques that target negative thoughts about sleep (the cognitive part) and teach patients to stop sabotaging good shut-eye (the behavioral part). CBT includes limiting the amount of time spent awake in bed, getting up at the same time every day, forgoing naps, and avoiding alcohol and caffeine before bedtime. There's a bit more to it, but the basics sound a lot like what your mother might tell you to do. The evidence behind CBT is increasingly solid and persuasive. A recent head-to-head study conducted by Harvard Medical School's Gregg Jacobs found that CBT worked better than sleeping pills both in the short term and the long term. Volunteers who received four half-hour sessions of CBT, plus a follow-up phone call, were able to fall asleep faster that their pill-taking counterparts, and this improvement persisted even after treatment was stopped. And of course, unlike pills, CBT has no side effects.
Nor is the therapy necessarily expensive. As few as two sessions have been shown to produce results. Nurses can be trained to provide CBT. So can psychology grad students. And there is a growing lay literature designed to help people try it for themselves. So, why aren't more insomniacs receiving this treatment?
For one thing, it isn't readily available. At the moment, there are few CBT practitioners specializing in sleep and few programs to train more of them. But even if their numbers begin to grow, the chances are small that this therapy will catch on as the standard best-practice approach. Already, patients who complain of sleeplessness to their primary care doctors are typically handed a prescription for Ambien (or referred to a psychiatrist who then writes the same Rx). Next month's ad launch will no doubt reinforce this pattern, by putting pills—with all their magic bullet simplicity—front and center in doctors' and consumers' minds. And while drug companies pour money into their own clinical trials, CBT has no sugar daddy. Proponents have to compete for grants from foundations or government sources like the National Institutes of Health. Nor do they have a friend in the insurance industry, which is generally less willing to pay for psychological treatments than for pills.
Direct marketing of drugs to consumers was initially welcomed by many patients'-rights advocates, who chafed at doctors' paternalism and sought to break their stranglehold on information. Conservatives continue to forcefully defend drug ads, contending that more information is a good thing and that consumers and doctors can be trusted to sort the useful information in the ads from the emotional pull of scenes of well-rested parents beaming across the breakfast table at their kids. If this faith in the market rings false to you, that's because there's something about medical information—the level of expertise required to make sense of it, the urgent nature of the needs it's designed to fill—that makes consumers particularly vulnerable to manipulation.
With its media megaphone, big pharma may increasingly have a stranglehold of its own. To make the best decisions about how to treat their insomnia, consumers need more information about all the available treatment options, not just the one that a profit-driven company is eager to promote. The new drug ads won't teach us about CBT. As Angell points out, doctors beholden to big pharma may not either. Which means we'll have to work harder to teach ourselves.