FDA Issues New Warnings and Lowers Dosage for Sleep Drugs

Earlier this year we wrote about the FDA’s concern over a certain class of sleep medication whose active ingredient is zolpidem. The feds said its dosage should be lowered.

Last week, as reported on AboutLawsuits.com, the FDA approved a new warning label for these drugs and lower doses for Ambien, Ambien CR, Edluar and Zolpimist. The alert explains that the drugs’ effects may linger dangerously into the day after they’re taken, especially for women.

In making the safety announcement, the FDA did not say whether the warning also would appear on Intermezzo, a short-acting version of the drug that Public Citizen’s Worst Pills, Best Pills website said could carry the same risks as Ambien. (Access to specific drug information on that site requires a subscription. We recommend it as an excellent source of independent information on drugs for consumers.)

As proposed in January, the recommended dose for women of immediate release products is now 5 milligrams (mg) instead of 10 mg; for the extended release drugs, it’s 6.25 mg instead of 12.5 mg. Women are more susceptible to lingering side effects because they eliminate the drugs slower than men. Recommended doses for men are either the lower or higher amount. They should begin with the lowest dose; if it’s not effective, they can try the more potent compound.

The label also warns against driving or engaging in activities requiring mental alertness the day after taking any version of the meds. One side effect, drowsiness, is obvious; but for some users, their mental capabilities can be compromised even if they feel fully awake.

AboutLawsuits.com explained a few months ago that researchers had found a link between sleep medication and a higher risk of having an auto accident. That story said that nearly 45 million prescriptions containing zolipidem were dispensed in 2011.

A study conducted by the Substance Abuse and Mental Health Services Administration reported that emergency room visits related to sleeping medications increased 220% from 2005 to 2010-so nearly 20,000 people visited ERs because of injuries or side effects of Ambien or similar drugs in 2010 versus 6,000 in 2005.

Other side effects of sleeping medications are:

  • headaches
  • dry mouth
  • constipation
  • difficulty concentrating
  • dizziness
  • rebound insomnia (when you stop taking a drug and the original symptoms return, only worse).

If you suffer from insomnia, prescription sleep drugs should be the solution of last recourse. Try these measures first:

  • Exercise regularly, about six hours before you want to sleep.
  • Avoid napping.
  • Go to sleep and wake at the same time every day.
  • If you’re worried, write your concerns down before going to bed.
  • Practice a relaxing bedtime ritual, like a warm bath or listening to calming music.

To learn more about insomnia, visit this page on the National Sleep Foundation website.

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