Sleep News

INSOMNIA || Drugs and Sleep: If you have been taking Ambien (zolpidem) long-term (since before 2013), please read this

Many people who have been taking the “Z-class” hypnotic sleep aid known as Ambien (generic: zolpidem) for insomnia over the last few years may be taking too much.

This oversight could easily happen: a patient is given a prescription for Ambien that they just refill “as needed.” If they are still receiving a dose that matches their pre-2013 dosage, and they are female, their doctor and/or pharmacist may not have noticed and changed the order to match new regulations.

In 2013, the FDA reduced the standard dosage of Ambien by half specifically for women to account for side effects that left regulators concerned about morning-after impairment, especially behind the wheel of a car. The typical 10mg dosage (labeled Ambien, Edluar or Zolpimist) and the 12.5mg dosage (labeled Ambien CR) were reduced to 5mg and 6.25mg, respectively, after concerns that these psychoactive drugs were causing patients to get into automobile accidents several hours after the effects of the drug should have worn off.

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If you take any of these versions of Ambien as needed for insomnia, and you are female, please confirm you are receiving and using the updated dosage. If not, contact your doctor and/or pharmacist to inquire into why you are still receiving the same dosage. The concern is less about side effects and more about public safety; all patients using these medications need to be warned of their impact on day-after driving, not only to protect themselves, but to protect those on the road.

The FDA, in January 2015, launched a new draft of guidelines for pharmaceutical companies to consider when developing psychoactive drugs like Ambien, which can increase the likelihood of driving impairment. The agency is now recommending “driving studies” be added to drug development requirements in order to evaluate a patient’s ability to operate a motor vehicle several hours after taking the drug.

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