Tags: FDA Requiring Lower Doses for Sleep Drugs

FDA Requiring Lower Doses for Sleep Drugs

By Nick Tate   |   Wednesday, 27 Feb 2013 06:19 PM

The U.S. Food and Drug Administration is requiring manufacturers to lower the recommended dose for sleep drugs approved for bedtime use that contain zolpidem, the most widely used active ingredient in prescription sleep medications.
The ingredient — contained in the brand name drugs Ambien, Ambien CR, Edluar, Zolpimist, and in generic sleeping pills — may remain high enough in the blood of people who take them to make them less alert in the morning and even impair certain activities that require mental acuity.
The FDA said risks are highest for people who take products containing extended-release zolpidem (Ambien CR and generics). Women are especially vulnerable because zolpidem is cleared from the body more slowly in women than in men.

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The recommended doses of Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing.

The FDA also issued the following recommendations for people who take sleeping pills:
  • Be aware that sleep drugs can cause impaired alertness the next morning, even if you feel fully awake.
  • Talk to your healthcare professional about how to take the lowest effective dose of sleep drugs.
  • Don’t assume that over-the-counter sleep medicines are necessarily safer alternatives to prescription drugs.

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