A number of high-profile psychiatrists are contesting claims that ads for Sepracor's Lunesta tout as key benefits of the sleep drug, The Boston Globe reported.
One objection centers on how long the pills can safely be taken. Lunesta.com states that the drug is approved for "long-term use," and similar language appears in Lunesta print and TV promotions. Lunesta's label states that the drug is indicated for treating insomnia but does not mention extended use; the FDA did not place a time restriction on the drug. That gives it an edge, as other prescription sleep aids on the market are required by the FDA to carry wording indicating "short-term" use.
A psychiatrist affiliated with the University of Pittsburgh said this claim makes the advertising a "little misleading" and that more long-term studies are needed.
TV ads also say that the drug helps patients "sleep all through the night" and that "A full night = 8 hours." A Harvard Medical School psychiatrist contests that claim, saying it isn't backed by a Lunesta study that helped the drug gain approval. The study, which appeared in the journal Sleep, showed patients using Lunesta had a median sleep time of only about 6 hours, 20 minutes.
The Sleep study also showed these patients registered a mean average of about 45 minutes to fall asleep. Insomnia is defined as failure to fall asleep within 30 minutes. But the median time it took subjects to fall asleep was 30 minutes, and the Lunesta ads are accurate based on this, according to the lead author of the study.
The FDA declined to discuss reviews of any particular company's advertising with The Globe.
Lunesta came on the market in April and generated $86 million in sales through June, according to IMS Health, trailing only Sanofi-Aventis' Ambien in market share.