FDA wants lower doses for sleeping aids
The Food and Drug Administration is requiring manufacturers of certain sleeping pills, including the widely prescribed Ambien, to reduce current recommended dosages.
Ambien, Ambien CR, Edluar and Zolpimist, as well as the generic forms of Ambien, all contain the ingredient zolpidem, which can cause morning drowsiness. Ambien is considered an effective medication for adults and seniors who can't sleep, although the National Institutes of Health cautions it can cause impaired motor and cognitive function in the elderly. Researchers also found last year Ambien is among the sleeping pills that increase the risk of hip fracture in nursing home residents.
Studies have shown that women eliminate zolpidem at a slower rate than men, which was part of the logic behind the FDA making manufacturers change the dosage recommendations.
The recommended dosage for women will now be 5 milligrams (down from 10) and 6.25 mg for Ambien CR (down from 12.5). For men, the FDA has said that healthcare professionals should consider prescribing the lower doses as well. The recommended doses of Intermezzo, a zolpidem product for middle-of-the-night awakenings, isn't changing, as the label already recommended a lower dose for women when it was approved in November 2011.
In 2007, the FDA approved the first generic versions of Ambien, although it also asked manufacturers that year to strengthen product labeling related to risks. As the popularity of the medication grew, the FDA began receiving reports that some who took Ambien were impaired when driving the next morning, and future studies bore this out.
FDA's change does not affect sleeping aids such as Lunesta and Sonata, which have different ingredients.
However, the agency used the opportunity to remind people that morning drowsiness isn't limited to zolpidem products. It encouraged healthcare professionals to prescribe the lowest dose available in a sleeping pill in order to treat a patient's insomnia.