FDA approved the use of Ambien in 1992. Now, with over 20-years of use, the FDA is changing its recommended dosage guidelines for safety reasons.  New research is showing that taking the medication zolpidem (i.e. Ambien) at night can impair morning alertness in women. The data implies that Ambien’s sedative and hypnotic effects linger longer in the body then previously thought. These effects can be subtle. Someone can feel totally awake, but their response time may be impaired in activities that require alertness, like driving. The lingering next morning impairment is greater in women since women process the medication at a slower rate then men.

The FDA is recommending that the starting dose of Ambien be lowered from 10mg to 5mg for the immediate release products and from 12.5mg to 6.25mg for the extended-release products.

The FDA is not infallible. Even though it has endorsed a drug at a given dosage, we still have to be wary when selecting FDA-approved medications. The long-term side effects of many drugs are often unknown until the drug has been in use for several years. I am not saying don’t trust the FDA, but we cannot blindly accept its recommendations without being aware that this may not be the last word on safety.