What's one of the FDA's biggest worries about sleeping-pill safety? Hint: It's not your usual sort of adverse event. It's more like a bank shot off the human body than a hit to the body itself: Auto accidents caused by still-sleepy drivers. It's the concern the FDA raised about the recently approved middle-of-the-night sleep aid Intermezzo--and the reason why the agency is requiring drugmakers to cut women's dosage of common insomnia remedies.
The FDA says it's requiring drugmakers that sell sleep remedies containing zolpidem--the active ingredient in Sanofi's ($SNY) blockbuster pill Ambien--to halve the recommended dose for women. Studies have shown that the usual dose can leave some people so sleepy in the morning that they're at risk for accidents. Women eliminate zolpidem from their bodies more slowly than men do, the agency says.
In fact, The New York Times reports, up to 15% of women have risky zolpidem levels in their blood 8 hours after taking the drug. In men, that group amounts to 3%. The new labeling will also instruct doctors to consider a lower dose for male patients.
In addition to immediate-release Ambien and its generics, the new dosing requirements apply to the sublingual form Edluar (Meda Pharmaceuticals) and oral spray Zolpimist (NovaDel). For those products, the dose should be cut to 5mg from 10mg. For the extended-release form, Ambien CR, the dosage for women should be 6.25mg rather than 12.5mg. In both cases, the lower dose is already available to on the market, the FDA says.
"Most people thought that by the morning it is gone," Dr. Robert Temple, a deputy director in the Center for Drug Evaluation and Research, told the Times. "What we're reminding people is that is sort of true, but that in some women who take a full 10 milligram dose, and in a lot of people who take the control release dose, it is not entirely true. Some people will be impaired in the morning."