The Food and Drug Administration, citing safety concerns, has called on manufacturers of the drug Ambien and its generic equivalents to lower the standard dosages of the insomnia drug now sold, and it is warning physicians that at current dosages, some patients are at risk of impairment in the morning.
The agency cited new data showing that the morning after taking the medication, some patients continued to have blood levels of zolpidem, the active ingredient in Ambien, that could disrupt driving and other activities that require alertness. That problem is more common for women, who clear the medication from their systems more slowly, and for those who use the extended release form of the medication, the FDA said in a statement.
In prescribing the immediate-release form of zolpidem to patients with sleep difficulties, physicians should routinely recommend that women take a 5-milligram dose instead of a standard dose of 10 milligrams, the FDA recommended. For men, a standard dose would be between 5 and 10 milligrams. These forms of zolpidem are marketed as generic medications under names such as Edluar and Zolpimist as well as under the name Ambien.
The current standard dose for extended-release Ambien -- which is not available as a generic medication -- is 12.5 milligrams, but should be cut in half -- to 6.25 milligrams for women, the FDA recommended. For men, the new standard dose can start at 6.25 milligrams but go up to 12.