Changes to Insomnia Drug Labels Affect Dosing, Warnings

The FDA has approved label changes specifying new dosing recommendations for zolpidem-containing products: Ambien (zolpidem, Sanofi Aventis), Ambien CR (zolpidem extended-release; Sanofi Aventis), Edluar (zolpidem tartrate sublingual tablets; Meda), and Zolpimist (zolpidem tartrate oral solution spray; ECR). The label changes are a result of data demonstrating the risk of next-morning impairment with these insomnia medications.

In addition, the FDA is warning that patients who take Ambien CR (6.25mg or 12.5mg) should not drive or engage in other activities that require complete mental alertness the day after because zolpidem levels can remain high enough the next day to impair these activities.  This update has been added to the Warnings and Precautions section of the Ambien CR label.

The new dosing schedule as previously recommended by the FDA in January is as follows:

  • Initial dose of immediate-release zolpidem (Ambien, Edular): 5mg for women, and either 5mg or 10mg for men
  • Initial dose of extended-release zolpidem (Ambien CR): 6.25mg for women, and either 6.25mg or 12.5mg for men
  • If lower doses (5mg for immediate-release and 6.25mg for extended-release) are not effective, the dose can be increased to 10mg and 12.5mg, respectively.

For more information visit the FDA website