Sleep Medication Dosages Reduced

Zolpidem requires lower dosages says FDA

(RxWiki News) Taking sleeping medication may help you get to sleep in the evening. But it may also make you a less alert and possibly more dangerous driver the next morning, according to the FDA.

The US Food and Drug Administration recently released two announcements related to dosages for the most common sleep medication ingredient.

The FDA announcement for the general public reminds everyone not to take more than the recommended dosage of sleeping medication, especially if it is made from zolpidem. Medications with zolpidem include Ambien, Edluar and Zolpimist.

The FDA also instructed pharmaceutical manufacturers to reduce the standard dosage recommendation for these medications with zolpidem.

"Take only the recommended sleep medicine dosage."

The announcements came following new data related to how long zolpidem can remain in individuals' bodies after they take it. The extended-release forms of zolpidem, such as Ambien CR, may especially remain high enough in adults overnight that their alertness is lower than it should be the following morning.

The reduced alertness that can be caused by taking zolpidem the night before could contribute to drowsiness or slower reaction time during driving and other activities that require alertness.

Even the immediate-release form of zolpidem found in Ambien, Edluar and Zolpimist may impair driving and other activities the following morning, the FDA stated.

The FDA has therefore notified manufacturers that they need to reduce women's dosages for medication containing regular zolpidem from 10mg to 5mg. They cut the dosage of extended-release medications with zolpidem for women from 12.5mg to 6.25mg.

Although not requiring it, the FDA is also recommending that manufacturers consider reducing men's dosages of zolpidem products to 5mg for regular and 6.25mg for extended-release as well.

However, patients already taking 10mg or 12.5mg should not immediately stop taking the medication.

"People who are currently taking the higher doses (10 mg or 12.5 mg) of zolpidem-containing insomnia medicines should continue taking the prescribed dose as directed until discussing with their health care professional how to safely continue to take the medicine," the FDA stated. "Each patient and situation is unique, and the appropriate dose should be discussed with a health care professional."

The FDA did not recommend any changes for the medication Intermezzo, which also contains zolpidem and is used for patients who wake up in the middle of the night. The dosage for Intermezzo remains 1.75mg for women and 3.5mg for men.

Approximately 9 million patients filled prescriptions in 2011 for medications with zolpidem, according to the FDA.

Meanwhile, the FDA's Adverse Event Reporting System includes about 700 reports of car accidents or driving problems related to taking zolpidem. However, information on the zolpidem dosage, when it was taken, the time the accident occurred and the presence or absence of alcohol or other drugs was not recorded for many of these reports.

Until the recent data from clinical trials had become available, the FDA was waiting to make any recommendations related to zolpidem dosages.

Review Date: 
January 10, 2013