Sepracor Tested Sleeping Pill Lunesta on Kids

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The FDA stopped two clinical trials run by Sepracor studying sleeping pill Lunesta in children. The July 4 weekend is traditionally one of those times when companies drop bad news into the media in the hopes that America will be too busy eating and drinking to notice. This year was no exception as Sepracor unveiled this release, which states that a trial of its new depression candidate failed and oh, by the way, our sleeping-pills-for-kids experiments have been stopped, too. The statement said:

In April 2009, Sepracor initiated two additional pediatric studies in accordance with the FDA’s Written Request. The FDA has notified us that these two studies have been put on clinical hold due to its concerns regarding non-clinical data that could be relevant to the administration of eszopiclone in children. The clinical hold does not relate to any findings observed in the pediatric clinical studies…

It is not clear exactly what is being studied. But ClinicalTrials.gov lists these three trials of Lunesta in kids. One for “Children and Adolescents With Attention-Deficit/Hyperactivity Disorder - Associated Insomnia,” a second for the long-term safety effects in the same condition, and a third to see whether kids recovering from burns get better sleep with Lunesta or Takeda’s Rozerem.

The math suggests one of these trials is still under way. If you really want to scare yourself regarding the amibitions Sepracor has for Lunesta, do a search for the brand name. It brings up 48 different tests for unapproved indications as varied as use in patients with Parkinson’s Disease, shift workers, schizophrenia, cancer and low back pain.

Hat tip to Internet Drug News.

Tags: FDA, Sepracor Inc., Lunesta, Federal Government, Government, Jim Edwards

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

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