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FDA cuts dose of Ambien and related insomnia drugs

Consumer Reports News: January 10, 2013 04:34 PM

If you take a sleeping medication that contains zolpidem (Ambien, Ambien CR, Edluar, Zolpimist, or generic), you could still have levels in your body the next morning that are high enough to impair driving, even if you feel wide awake. That's according to the Food and Drug Administration, which said Thursday it was requiring manufacturers to lower the recommended dose of the insomnia drugs by half to help reduce the risk of traffic accidents. Women are especially at risk because they clear the drug slower than men.

The FDA said the move was prompted by data from clinical trials and driving simulation studies that showed that both the extended release and immediate release formulations of zolpidem could impair next-day driving or other activities that require altertness. The agency had concerns about zolpidem's impact on driving because it received 700 reports of people whose driving ability was impaired or who were in an automobile accident after taking the medication.

For women, the recommended dose of immediate release zolpidem (Ambien, Edluar, Zolpimist, and generic) has been reduced from 10 mg to 5 mg. The recommended dose for extended release zolpidem (Ambien CR and generic) has been cut from 12.5 mg to 6.25 mg. Men should consider the lower doses also. The reduced dose does not apply to the low-dose zolpidem pill, Intermezzo, approved by FDA in late 2011. If you take one of these medications, talk to your doctor about how to safely reduce your dose.

Insomnia medications, including over-the counter drugs, such as diphenhydramine (Nytol, Sominex and generic) or doxylamine (Unisom and generic), can cause other side effects too, including daytime sleepiness, dizziness, and rebound insomnia. Sleep-walking, sleep-driving, sleep-eating, memory lapses, and hallucinations have also been reported.

So if you suffer from insomnia, we recommend first trying to improve your sleep habits or making other lifestyle changes, including avoiding alcohol and caffeine before bedtime and not using computer and electronic devices in bed. Research has found that these measures can often help resolve mild insomnia and make medications unnecessary.

Read more about insomnia medications in our free Best Buy Drugs report. And check out our sleep report for tips on how to relieve insomnia.

Source:

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) [FDA announcement]

Steve Mitchell


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