Label Changes for:
Lunesta (eszopiclone) tablets
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
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
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.