![]() ![]() And when its use was stopped “cold turkey,” according to Dr. The studies of Lunesta found that patients taking it for the long haul did not build up a tolerance for the drug - a concern that worries many doctors who prescribe sleep aids for long periods. Several lasted six months, and one was extended to a year of continuous use, far longer than the 12-week trials that led to FDA approval of Ambien and Sonata.Īn estimated 70 million people suffer from sleep disorders and wakefulness, according to the National Institutes of Health, and 60% of those are chronic insomniacs. It also launched five separate studies of the drug’s use for chronic insomniacs - people who regularly have trouble falling or staying asleep. But in preparing the prescription sleep aid for FDA approval, Sepracor did not only sponsor short-term studies demonstrating the drug’s effectiveness for those who sometimes can’t fall asleep. The newest drug is a derivative of a medication long available in Europe and Latin America. It will cost about 75% more than Sonata and Ambien, the two new-generation sleep medications that, like Lunesta, are called non-benzodiazepines. Sepracor Inc., the Massachusetts-based pharmaceutical company that manufactures Lunesta, says it will dispatch an army of 1,250 sales representatives to promote the drug to primary care physicians, psychiatrists and hospital physicians - the doctors who are most often the first to spot and treat insomnia - about the new medication’s value.Īt an average wholesale price of $3.70 per tablet, Lunesta will not be a cheap sleep, however. In approving other sleep medications, including the widely used medications Ambien and Sonata, the FDA has consistently cautioned that they should be used for short periods - usually no more than a week to 10 days - because longer-term studies of their safety and effectiveness have not been done. Second, it is the first prescription sleep drug that the Food and Drug Administration has essentially declared safe and effective for long-term use. ![]() This double-barreled approach offers a balm for those who tend to waken frequently during the night or too early in the morning. When taken at bedtime, the drug not only puts insomnia sufferers to sleep for a full six or seven hours it also carries a low risk of grogginess the next day. Lunesta breaks new ground on at least two counts. On late-night TV, where insomniacs gather anyway, that’ll buy a lot of advertising, and the drug, named Lunesta, is expected to be one of this year’s most heavily marketed medications. But while it is already the talk of the town among sleep-medicine specialists, the drug’s manufacturer is planning a $60-million campaign to take the news directly to the sleepless and baggy-eyed in advertisements wedged between reruns, classic movies and political gabfests. In mid-December, the Food and Drug Administration approved a new prescription sleep aid - a hypnotic, in medical parlance - called eszopiclone. ![]() The nation’s insomniacs will need only to turn on late-night television in the next several months to learn there’s a new kid on the block in the $2-billion market for sleep drugs.
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