Label Changes for:

Lunesta (eszopiclone) Film Coated Oral Tablets

February 2014

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

February 2014

6 ADVERSE REACTIONS

6.2 Post-Marketing Experience..added paragraph
  • In addition to the adverse reactions observed during clinical trials, dysosmia, an olfactory dysfunction that is characterized by distortion of the sense of smell, has been reported during post-marketing surveillance with LUNESTA. Because this event is reported spontaneously from a population of unknown size, it is not possible to estimate the frequency of this event.
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