• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Lunesta (eszopiclone) Film Coated Oral Tablets

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

 

May 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.1 CNS Depressant Effects and Next-Day Impairment
  • The risk of next-day psychomotor impairment is increased if LUNESTA is taken with less than a full night of sleep ...section updated

 

February 2014

Summary View

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.