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U.S. Food & Drug Administration Changes Sleep Drug Dosage Guidelines


Could a sleeping pill leave you groggy and tired after waking up? Could this increase your chances of having an accident while driving or doing another safety sensitive task? According the U.S. Food & Drug Administration (FDA), the answer appears to be yes. This announcement has major implication for managers supervising workers taking sleeping pills to combat shiftwork related fatigue.

In a major new guideline published last week ago, the U.S. Food & Drug Administration (FDA) made sweeping changes to its recommended dosages of sleep drugs.

At the heart of the new recommendation was emerging research in the effect of sleep drugs, and specifically zolpidem, on women,. The new guidelines suggest lowering the recommended dosage of sleep drugs containing zolpidem by as much as half. Zolpidem is a commonly used compound in sleep medication such as Ambien and Zolpimist, along with others. Zolpidem works by binding to receptors in your brain responsible for sedation, helping you to fall asleep quickly and deeply. In theory, the zolpidem in drugs such as Ambien allow you to get a great night’s sleep and wake up rested the next morning.

Zolpidem is the active compound in both immediate release pharmaceuticals, like Ambien, which begin working immediately after ingesting them, as well as in extended release pharmaceuticals, like Ambien CR.

However, recent studies have shown that zolpidem in high doses lingers in the body, leading to fatigue and decreased vigilance after waking up from sleep. In fact, according to the FDA, zolpidem may remain present in your body after wakeup at levels high enough to impair driving or other activities requiring alertness – like many safety-sensitive shiftwork jobs.

Women eliminate zolpidem from their bodies more slowly than men, so the FDA’s new guidelines specifically target dosages for women, but they also suggest men lower their dosage where possible. The new guidelines require that doctors adjust their prescriptions in the following ways:

  • Lower the dose of zolpidem for women from 10mg to 5mg for immediate release pharmaceuticals containing zolpidem
  • Lower the dose of zolpidem for women from 12.5mg to 6.25mg for extended-release pharmaceuticals containing zolpidem
  • For all patients, male and female, the FDA suggests prescribing the lowest possible dose to treat the patient’s symptoms

So what if you or shiftworkers you manage are already taking a drug which contains zolpidem to help with sleep? Well, the FDA suggests continuing to take your prescribed dose, until you can get in touch with a healthcare provider to determine the best dose for you. They note that for most women, and many men as well, a lower dose won’t actually decrease the effectiveness of pharmaceuticals in treating insomnia or other sleep problems. Stay aware of the fact that zolpidem may linger in the body even if people feel awake the next morning - so make sure you remind people to take precaution while driving or doing other activities which require alertness.

And remember: sleeping pills are designed to be a short-term solution to insomnia. Many of the sleeping issues shiftworkers have can be improved with shiftwork lifestyle training and education. CIRCADIAN’s research has shown that this type of training can improve shiftworker sleep duration and reduce fatigue on the job. 

Sources:

U.S. Food & Drug Administration. “FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)” Jan. 2013 available at http://www.fda.gov/Drugs/DrugSafety/ucm334033.htm

 

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