The Food and Drug Administration is requiring manufacturers of Ambien, Ambien CR, Edluar and Zolpimist to lower the recommended dosage for these medications and their generic counterparts commonly prescribed to treat insomnia.

New data confirm that these medications, which contain the active ingredient zolpidem, remain in patients’ bloodstreams longer than previously believed.  Because the meds are all specifically approved for use at bedtime, the FDA is concerned that zolpidem levels may be high enough the morning after use to impair activities requiring alertness,  including driving.

Studies have revealed that risk for next-morning impairment is highest for women and for patients taking extended-release forms of these medications. Although drowsiness is listed as a common side effect on the labels of all insomnia drugs, the FDA is reminding people that insomnia drugs can weaken mental alertness the morning after use, even if they may feel fully awake.

As the agency continues to evaluate risks associated with taking zolpidem drugs as
well as other insomnia medications attainable without a prescription, the FDA is making the following recommendations for healthcare professionals:

  • Lower the recommended dose of zolpidem for women from 10 mg to 5 mg for immediate-release products including Ambien, Edluar and Zolpimist and from 12.5
    mg to 6.25 mg for extended-release products like Ambien CR.
  • Prescribe the lowest dose possible for any insomnia drug needed to treat a patient’s
    symptoms.
  • Inform patients that impairment from sleep drugs can be present despite feeling fully awake.
  • Report adverse events, including falls, or other side effects related to the use of these products through the MedWatch Safety Information and Adverse Event Reporting Program:
    • Complete and submit a report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

To learn more by reading the FDA’s MedWatch alert, click here.