FDA recommends lower dose for common sleeping pills that treat insomnia

The FDA issued a recent safety announcement and consumer update requiring drug makers to lower the recommended doses for products that contain zolpidem. The recommendation is based on concern that the current dose recommendation may be too high, and as a result people may still be drowsy the following morning. This can be a health and safety risk, especially for people who drive in the morning.

The new dose limits apply to the following medications:

Ambien, Edluar and Zolpimist

  • Dose lowered from 10 mg to 5 mg for women
  • Doctors also should consider prescribing the lower dose of 5 mg for men.

Ambien CR (extended-release): 

  • Dose lowered from 12.5 mg to 6.25 mg for women
  • Doctors also should consider prescribing the lower dose of 6.25 mg for men.

Intermezzo:

  • No changes.  Labeling already recommends a lower dose for women than men.
2013-01-11T00:00:00+00:00 January 11th, 2013|Professional Development|