Doctors Criticize Sleeping-Pill Ads

• Drug News • Aug 19, 05

An advertising campaign by Sepracor Inc. is drawing fire from psychiatrists who say the Marlborough company misrepresents its new sleeping pill.

The complaints from several high-profile psychiatrists hinge on language in advertisements for the prescription drug, Lunesta, and illustrate how drug makers and the Food and Drug Administration can expect stiff scrutiny of product claims as the debate over direct-to-consumer advertising heats up.

The company won’t discuss the criticism of it advertisements—which appear in print, on television, and on the Internet—except to say they were reviewed by the FDA before its $60 million campaign was launched this year.

One print ad says Lunesta is “the first and only prescription sleep aid approved for long-term use.” Similar phrases appear on Sepracor’s website for the drug, lunesta.com, and in television ads. They depict restless people being lulled to sleep by what appears to be a luna moth, which is active at night.

But while Lunesta’s label says the drug is intended to treat insomnia, it does not mention how long the pills can safely be taken. The FDA did not require the label to specify that the drug is for “short-term” use, as it has for other prescription sleep aids on the market.

University of Pittsburgh psychiatrist Daniel Buysse, who is also a consultant to Sepracor, said that makes the Lunesta advertising “a little bit misleading.” He believes more long-term studies of sleeping-pill safety is needed.

Gregg Jacobs, a Harvard Medical School assistant professor of psychiatry, said some of the ad claims aren’t backed by a study that helped Sepracor receive FDA approval for the drug this year. The study, in the medical journal Sleep, showed that patients using Lunesta fell asleep about 20 minutes faster than those taking a placebo, but they still took about 45 minutes to dose off, according to the study’s mean average. Insomnia is often defined as failure to fall asleep within 30 minutes.

Jacobs also disputes a TV ad claim that “Lunesta helps most people sleep all through the night.” As those words are spoken, screen text reads, “A full night = 8 hours.” The Lunesta website says a study showed “most people who took Lunesta slept an average of 7-8 hours.” But the Sleep study reported a median sleep time of only about 6 hours, 20 minutes.

“Patients who took this drug did not become normal sleepers,” Jacobs said.

University of California psychiatrist Daniel F. Kripke makes similar criticisms of the drug and how it is advertised. Jacobs and Kripke have said behavioral therapy is preferable to pills for treating insomnia long-term, a hotly debated issue in the field of sleep medicine, and they have previously criticized Sepracor in letters in Sleep.

The lead author of the Sleep article, Duke University psychiatrist Andrew Krystal, who is also a member of Sepracor’s advisory board, said in an e-mail that Lunesta ads are accurate based on the median time it took patients to fall asleep: 30 minutes. He called that a more meaningful measure than the 45-minute mean average cited by Jacobs.

A spokeswoman for the FDA said it would not discuss reviews of a particular company’s advertising, such as why Sepracor can claim Lunesta is “approved for long-term use.”

David Neubauer, a Johns Hopkins University sleep specialist, said the FDA likely approved the phrasing because “It’s not deeply misleading. The FDA has said there is not a time restriction, so it’s an easy interpretation.”

Sepracor’s fortunes depend on Lunesta, which got off to a fast start in April when it came on the market. Data from market researcher IMS Health show it beat three other popular sleeping pills by generating $86 million in sales through the end of June and trailed only Sanofi-Aventis’s Ambien in market share.

Older sleeping pills like Halcion worked by activating a chemical switch in the brain known as the benzodiazepine receptor. Ambien and Lunesta work on the same receptor, but more specifically, which reduces hangovers and other side effects.

How Sepracor markets Lunesta is part of a broader debate over advertising aimed at consumers. The FDA sometimes suggests changes, even after ads appear. For instance, in February it asked California drug maker Amgen to pull TV ads for its psoriasis drug Enbrel, saying they showed featured models with clearer skin than patients could expect to see by using the drug.

Senate Majority Leader Bill Frist, Republican of Tennessee, has called for a two-year ban on the advertising of new drugs. Manufacturers are pushing for compromises, such as Pfizer’s announcement last week that it will not advertise new prescription drugs to consumers for six months. The company said the delay will allow doctors to be educated about the products without being inundated with requests for prescriptions from patients.

That goes further than guidelines proposed by the pharmaceutical industry’s trade group in late July, which did not call for a moratorium. Drug makers also said advertising should clearly state risks and include plain language. Sepracor said in an Aug. 2 release that it has adopted those guidelines.

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Source: The Boston Globe