FDA Orders Lower Doses Of Sleep Aids For Women
January 11, 2013

Dosages Of Popular Sleeping Drugs Must Be Lowered, Especially For Women

redOrbit Staff & Wire Reports - Your Universe Online

The US Food and Drug Administration (FDA) is requiring pharmaceutical companies to lower the recommended doses of popular sleeping pills, due to the potential risk of injury resulting from morning drowsiness associated with the medications in recent studies.

According to Reuters, studies have demonstrated that pills containing the prescription drug zolpidem (which include products sold under the brand names Ambien, Edluar, Stilnox, Sublinox, and Zolpimist) could interfere with a person´s alertness and coordination during the early hours of the following day. The risk was highest for patients using extended-release forms of the sleeping pills, the news organization noted.

As a result, the FDA is requiring manufacturers to lower the recommended dosage for women by half — “from 10 milligrams to 5 milligrams for regular products, and 12.5 milligrams to 6.25 milligrams for extended-release formulations,” reports AP Health Writer Matthew Perrone.

The agency is recommending that those doses also be applied to men, but they are not strictly enforcing that requirement, he said. Furthermore, the agency is recommending that doctors prescribe the lowest amount of zolpidem and similar insomnia medications that effectively treat a patient´s symptoms, while also warning them that morning impairment from the drugs is possible, even in individuals who feel completely awake, added Susan Jeffrey of Medscape Medical News.

“The agency decided to take action after recent driving simulation studies showed that, in some patients, drug levels remained high enough to cause difficulty driving. The data came from company studies of Intermezzo, a new form of zolpidem which was approved in 2011 for people who wake late at night and can't get back to sleep,” Perrone said.

“The data showed that 33 percent of women and 25 percent of men taking extended-release zolpidem had enough of the drug in their blood to interfere with driving as much as eight hours later. When the dose was cut in half only 15 percent of women and 5 percent of men had those same drug levels,” he added. “FDA analysis was unable to determine why women metabolize zolpidem so much more slowly than men.”

Lowering the dosages will mean that less of the medication will still be in a person´s system come morning, thus lowering the risk that it will cause users to be impaired while operating a motor vehicle, Sabrina Tavernise of the New York Times explained.

"Reports of aftereffects from sleeping pills have circulated for years, and some doctors questioned why the drug agency took so long to act. Mishaps with sleepy driving – and even strange acts of texting, eating or having sex in the night without any memory of it in the morning – have long been familiar to the medical community,” she added.

“In this case, the F.D.A. may be behind the eight ball. Few doctors will be surprised hearing about this. They´ll say, ℠Oh yeah, we´ve already seen this in our patients,´” Tufts University associate clinical professor of psychiatry Daniel Carlat told the times. Nonetheless, he said that the FDA´s new regulations “will be good for public health because it will get patients to ask their doctors about the appropriate dosage.”