Just do it. The Un-Cola. The Choice of a New Generation.

Time was that slogans and brand recognition were the exclusive terrain of readily available, commercial commodities. All that changed when, in 1997, the Food and Drug Administration clarified its rules regarding advertising, and pharmaceutical manufacturers were given the green light to promote their wares on television.

During the decade that has passed, the number and types of direct-to-consumer television advertising have steadily increased. In a study conducted by IAG Research quizzing consumers about the most memorable pharma-related advertising in the 2006-2007 television viewing season, three of the top five most recalled new prescription drug ads were aimed at individuals suffering from insomnia.

In addition to taking the top two spots, Sepracor’s 7-Day Challenge—part of a promotion for the company’s sleep aid Lunesta—was remembered over 50%1 more times than the average new prescription ad launched during that commercial season. Takeda’s Rozerem was barely nudged out of the number four spot to round out the top five.

IAG’s report suggests the reason these ads make such an impression is their infusion of recognizable iconic figures—from luminescent moths to Honest Abe.

“The fact that Lunesta along with other prescription brands, including Nasonex, Rozerem, and Vytorin, remain at the top is a testament to strong campaign development that continues to deliver seamless creative extensions that effectively break through the clutter and reinforce the brand identity synonymous with the icon present in the ads,” says Fariba Zamaniyan, senior vice president of IAG Research’s Pharmaceutical Practice. “Memorability isn’t just a function of big budgets, but rather strong creative concepts. The ranking includes campaigns with budgets big and small for brands both new and existing.”

Lots of airtime doesn’t hurt either. Since its launch in early 2005, Sepracor has allocated more than $200 million2 to advertising Lunesta. Creative continuity within an entire campaign also helps cut through the on-air clutter, according to IAG, adding to the list of reasons why consumers are able to recall specific ads and brands up to 24 hours later.

THE TRICKLE-DOWN EFFECT

No matter what the exact reason, there is little doubt the investment is paying off. A report from the Consumers Union of United States Inc, publisher of Consumer Reports magazine, found that the use of prescription sleeping pills increased almost 50% between 2001 and 2006.

Beyond the measure of effective advertising, however, what influence do these ubiquitous and well-thought-out campaigns have on patients and the physicians who treat them?

“I think they have had a huge positive impact, through increased awareness of sleep issues and problems,” says Daniel Loube, MD, FACP, FCCP, medical director, Pulmonary Medicine & Sleep Disorders, Providence Medical Group. “Now [patients] go to their primary care provider asking about restless leg syndrome or wanting to have their insomnia treated, whereas before, they may not have brought it up because they didn’t think it was treatable.”

It is possible that the initial benefit of increased awareness wanes over time, leading to a consumer-driven demand for the drug.

“It is a mixed blessing in my view. [The ads] do play a role in increasing awareness, especially of less common conditions, but as time goes by, the value of the advertisement changes,” says Lois E. Krahn, MD, Department of Psychiatry and Psychology, Mayo Clinic. “Companies are less likely to conduct direct-to-consumer [advertising] when they cannot predict positive financial returns because a disorder is rare, the treatment is relatively inexpensive, or treatment is short term. So, the benefits of increasing public education about a condition are less likely in this scenario.”

PERSUADING PATIENTS

There are roughly 70 million Americans who struggle with sleep problems, according to the National Commission on Sleep Disorders Research. About 40 million of them suffer from a chronic sleep disorder, while another 20 to 30 million deal with such problems intermittently.

For many of these individuals, a soothing ad promising an end to their sleepless nights is all the motivation they need to seek treatment. But often, the commercials are too effective, leaving consumers to believe the solution—and a good night’s sleep—is just a prescription away.

“If you just went through a week of US television, you would think the cure for insomnia has been identified and it’s simply a pill, when that is really quite at odds with what we know,” says Krahn. “At the end of the day, this is not a public service ad. Insomnia, in many ways, is a very complex illness, and most patients require a plan of several [elements], and maybe pills are on that plan, but it is in addition to other things.”

The expectation of an immediate cure can lead to frustration for patients and physicians alike. Individuals who think the drug is a surefire treatment are often disappointed to learn that treatments for most sleep disorders involved prolonged behavioral therapies, according to Loube.

“There are patients who only want to get a sleeping pill that works, and if the initial series of medications don’t work, they don’t want to return for behavioral therapy, further discussion, or assessment,” he says, noting that those who fall into this group often have higher-than-normal expectations because of other issues beyond just a sleep condition.

Because many insomnia treatments are prescribed to be used “as needed,” Krahn also wonders if the increased awareness might ultimately increase the frequency with which individuals make use of sleep meds already in their medicine cabinet.

“I wonder if these ads will prompt the patient to take the pill that night by playing on their fears of a bad night’s sleep; perhaps patients want to preempt [a bad night] by taking the medicine, and therefore are consuming more,” she says, noting the effect would not apply to medicines with a standard daily dose, but may act to lower the threshold to when someone might decide they need to take the pill. “The ads have this image of somebody who is sleeping so well, and as someone is getting ready for bed, they think, ‘I might as well take one after all; I won’t try to go without it.’ ”

WORKING WITH PCPS

No matter how impressive the bankroll putting sleep-aid ads on television, ultimately, the physicians are in charge of directing care. The fact that clinicians are just as inundated with drug ads as the average patient makes the relationship between sleep professionals and primary care and other referring physicians even more important.

“At the primary care level, they are aware of these brand-name products and there is a willingness [to prescribe them] on the part of doctors trying their best to manage insomnia within their offices,” says W. Vaughn McCall, MD, MS, professor and chairman for the Department of Psychiatry and Behavioral Medicine at the Wake Forest University School of Medicine, who has also conducted research supported by Sepracor, sanofi-aventis, and Mini Mitter. He references a position paper by the American Academy of Sleep Medicine that essentially notes that, in most cases, insomnia can and should be managed on the basis of an office evaluation. “In most instances, that is appropriate,” he says.

However, McCall emphasizes that this does not include more complicated cases of insomnia.

“What does concern me is I see a number of patients who have failed one sleeping pill after another, and when I ask them, ‘Has anybody taken a detailed history about your sleeping behavior and really tried to work with you at reshaping your approach to sleep?’ the answer is almost universally ‘no,’ ” he says. “I wish that before a patient is exposed to two or three, or more, different sleeping pills, there was some effort to take a good history and to help them reshape their sleeping behavior.”

Loube echoes that sentiment. “You want to encourage primary care providers to do simple things and to treat simple problems, but it’s important for them to refer patients for sleep medicine consultations when [those individuals] are failing simple initial therapy,” he says. “And it may not be for a sleep study—it may just be for assessment and management—but that assessment and management is pretty important to the patient, [especially] if they’ve failed therapy.”

Additional information could increase the likelihood that such initial treatments are as comprehensive as possible, according to McCall, who believes sleep specialists can help their referring physicians by demystifying the cognitive behavior approach to treating insomnia. He notes that boiling the process down to its essentials could alleviate much of the trepidation primary care physicians have in using cognitive behavior therapy.

“If we can simplify it so that people in primary care can feel comfortable that they can participate in this and that they can do things in a primary care office to reshape patients’ behavior and attitudes about sleep,” he says, “then they have a tool, other than sleeping pills, to treat patients with.”

Acknowledging that the theory behind cognitive behavior therapy may be complicated, McCall would encourage sleep professionals to explain that the treatment needn’t be.

“The data coming out [indicates] that without really even understanding the theory behind cognitive behavior therapy, [physicians can still] put in motion a handful of five or six simple things” to treat patients, he says.

Such techniques include helping patients decide when to go to bed each night, as well as the best time to start their day each morning; advising patients on making the best choices about consumption of caffeine and alcohol, and the timing of exercise; and giving the patients guidance on the best thing to do if they wake up in the middle of the night.

To Krahn, this level of outreach is particularly important as referring physicians begin to have more patients requesting drugs by name.

“While [these patients] may have some awareness that it is not a perfect pill, they at least want to be in the category of pharmaceutical treatments—not in the category of going to see a therapist and learning how to manage their insomnia through behavioral techniques,” she says.

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She also sees referrals as a chance to give primary care physicians more detailed information about specific sleep disorders.

“One of the most natural [opportunities] is when the individual patient is referred,” says Krahn, stressing how important it is that “a letter or a consultation takes place with the referring physician [discussing] that individual patient, explaining that, in this person’s case, [medications] could be one part among others to help him with his sleep problems.”

At which point, brand recognition might actually improve patient compliance.

“I don’t feel any doctor should be railroaded into prescribing a specific drug, but I do believe that any treatment is going to go better if there is some buy-in from the patient,” says McCall, who is also the medical director of Wake Forest’s sleep center. To that end, if a provider is choosing between two drugs that are equally defensible in terms of efficacy, it may be beneficial to prescribe the medication preferred by the patient. “Even if the patient’s preference seems illogical and is based more on marketing influence than fact, I might use the patient’s preference to help me pick between two drugs I already have in mind, because if the patient believes it will work, that will make the whole process go better.”

IN THE SPOTLIGHT

Opinions on whether direct-to-consumer ads for sleep meds are a boon or a detriment vary across professionals; however, it’s difficult to negate the fact that flooding American televisions with the commercials has raised awareness of the conditions they treat.

“At least now primary care providers are thinking about sleep issues; they are being discussed in the primary care physician’s offices, and I think that means there is more chance of referral for patients who need it,” says Loube.

McCall concurs. “The whole concept of direct-to-consumer advertising is an emotionally charged issue—and this is true whether you’re talking about sleep, depression, or other products—and people have strong opinions on both sides, but in regard to sleep products, I welcome it,” he says. “I think it generates conversation and dialogue about sleep, and it increases the sense of importance of sleep disorders, and I’m all in favor of that.”


Dana Hinesly is a contributing writer for Sleep Review. She can be reached at [email protected].

REFERENCES

  1. www.iagr.net/ne_press/pr_102307.jsp. Accessed May 6, 2008.
  2. Sleeping pills: are they worth the risks? Consumer Reports, September 2006. Available at: 2www.consumerreports.org. Accessed May 6, 2008.