FDA Recommends Lower Doses of Sleep Aids

By Kim Smiley

On January 10, 2013, the Federal Drug Administration (FDA) announced a new requirement to dramatically decrease the normally prescribed doses of sleep aids containing zolpidem, which includes Ambien, Edluar and Zolpimist.    Products containing zolpidem are the most commonly prescribed sleep aids with about 40 million dispensed in 2011.

A Cause Map, or visual root cause analysis, can be used to help understand this issue.  The first step in the Cause Mapping process is to fill in an outline with the background information for a problem, such as the date and location.  The bottom half of an outline is filled in with the impacts to an organization’s goals.  In this example, the safety goal is impacted because there is a risk of car accidents after patients used prescriptions containing zolpidem and drove a car.  There have been about 700 reports of car accidents after people used products contain zolpidem. The customer service goal is also impacted because this issue has generated some bad publicity for the companies that manufacture these drugs.

After the outline is completed, the next step is to use the impacts to the goals to ask “why” questions and add the answers to the Cause Map to show the cause-and-effect relationships.  Why is there a risk of car accidents? People may be driving while impaired because zolpidem makes you drowsy and they may have zolpidem in their systems.  Zolpidem is a sedative; it’s the active ingredient in a number of sleep aids.  People may still have zolpidem in their systems because millions of people take prescription sleep aids containing it and it stays in the body longer than was known.    Originally it was believed that it was safe to drive 8 hours after taking zolpidem, but the FDA determined that enough of the drug may be present to impair driving after 8 hours.  Women are especially at risk of impaired driving because they metabolize the drug slower.

The final step in the Cause Mapping process is to determine possible solutions that would prevent a problem from reoccurring.  In this example, the FDA determined that taking a lower dose of sleeping aids containing zolpidem would help reduce the risk of impaired driving and the potential for car accidents.  The new FDA requirements would lower the dose for women from 10 milligrams to 5 milligrams for immediate-release products and from 12.5 milligrams to 6.25 milligrams for the extended-release product. The safest option is always to take the lowest dose of any sleep aid that is effective.

If you use a sleep aid containing 10 mg or 12.5 mg dose zolpidem, the FDA recommends that you continue taking your medication as prescribed until you can contact your healthcare professional.

To view a high level Cause Map of this issue, click on “Download PDF” above.