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"We can't put any time frame on that," Cragle said. Meanwhile, the FDA said it wants Merck to provide the 5-milligram dose for use in patients also taking medicines in a group called CYP3A4 inhibitors. Those drugs include nonsedating antihistamines and infection-fighting drugs from antifungal medications and antibiotics to HIV medications. CYP3A4 inhibitors block an enzyme involved in breaking down many medications so they can be eliminated from the body. When that enzyme is slowed or shut down, levels of other drugs a patient is taking can build up too high in the bloodstream, causing dangerous interactions and side effects. If the FDA approves suvorexant, because it's considered a controlled substance it will then have to go through review by the U.S. Drug Enforcement Administration to determine what restrictions on sales are needed. Those typically include limiting the number of pills a patient can get at once or requiring a doctor's visit to get prescriptions for refills. In afternoon trading, Merck shares were down 17 cents at $47.16.
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