Indiplon, a short-acting sleeping medication intended for those middle-of-the-night wake-ups, failed to get the Food and Drug Administration nod yesterday, because the agency wants more research done in the elderly, in pregnant women, and in comparison with other sleeping medications. Meantime, popular sleep medications Ambien, Sonata, and Rozerem, all intended for use right before bedtime, have long been a source of help for people whose sleep apnea, hot flashes, or restless leg syndrome awakes them in the middle of the night, experts say.
None of the three have been studied or approved to be used this way, and people shouldn't try this method without consulting their doctors first, says Jerrold Kram, medical director of the California Center for Sleep Disorders. All three are included in a class called sedative-hypnotic drugs; the concern is that taking a dose with not enough hours left in the night "can leave you with some residual effects," says Kram, who has performed clinical trials of sleeping medications other than Indiplon. A general rule of thumb, experts advise, is to make sure you have at least four hours of sleeping time remaining before you take a sleeping pill. And because individual responses vary, leave yourself some leeway in the morning to see how you feel before becoming active.
Anyone who takes a sleeping pill before turning in probably shouldn't take a second pill during the night. One exception may be Sonata, Kram says, but it's important to consult your doctor for individualized advice. Sedative-hypnotic drugs carry risks, including severe allergic reactions and a tendency to act while asleep—driving, making phone calls, and eating while asleep, for example, according to the FDA.
Like Ambien and Sonata, Indiplon, if eventually approved, will be used to treat difficulty falling sleep, says Thomas Roth, director of the sleep disorders and research center at Henry Ford Hospital in Detroit. (Roth has worked as a consultant for all of the makers of the various prescription sleep medications, including Indiplon.) The fundamental difference, he says, is that Indiplon has a "very short-acting half-life," meaning that it leaves the body rapidly, and so it can be taken late at night. In a clinical trial sponsored by Indiplon's maker, Neurocrine Biosciences, Indiplon reduced the time it took to return to sleep when compared with placebo, and it also increased the amount of sleep gained following the return to bed. Patients also cited a better quality of sleep.
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