May 15, 2014 FDA Safety Communication regarding next day impairment associated with LUNESTA® (eszopiclone): Please note that there has been a change to decrease LUNESTA's recommended starting dose to 1mg at bedtime due to risk of next day impairment of driving and other activities that require alertness. Patients should consult with their doctor to determine the right dose to use.

Possible Side Effects

As with all medications, LUNESTA® (eszopiclone) has possible side effects. Before you begin treatment, it's important to know what these side effects are and to talk with your healthcare professional about the risks and benefits of taking LUNESTA.

When taking LUNESTA you may experience:

  • Unpleasant taste in your mouth, dry mouth
  • Morning drowsiness
  • Dizziness
  • Headache
  • Symptoms of the common cold

Do not drive or do any other dangerous activities after taking LUNESTA until you feel fully awake. You may still feel drowsy the next day after taking LUNESTA.

Possible serious side effects of LUNESTA include:

  • Getting out of bed while not being fully awake and doing an activity you do not know you are doing. To learn more, read the LUNESTA Medication Guide.
  • Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
  • Memory loss
  • Anxiety
  • Severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking LUNESTA.

These are not all the side effects of LUNESTA. Ask your healthcare professional for more information. Call your healthcare professional right away if you have any of the above side effects or any other side effects that concern you while using LUNESTA. You may report side effects to the FDA at 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION
Do not take more LUNESTA than prescribed. LUNESTA acts quickly, so take it right before bed, and only if you have 7-8 hours to devote to sleep. Do not take LUNESTA if you are allergic to anything in it. LUNESTA should not be taken together with alcohol or other sedative hypnotics. The morning after you take LUNESTA your ability to drive safely and think clearly may be decreased. Until you know how you will react to LUNESTA, you should not drive or perform other activities that require complete mental alertness the day after use. Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems. LUNESTA may cause serious side effects that you may not know are happening to you including daytime sleepiness, not thinking clearly, acting strangely, confused or upset, or walking, eating, driving or engaging in other activities while asleep. Other abnormal behaviors include aggressiveness, agitation, hallucinations and confusion. In depressed patients, worsening of depression including risk of suicide may occur. These risks may increase if you drink alcohol. Severe allergic reactions such as swelling of the tongue and throat occur rarely and may be fatal. Call your doctor if you experience these or any effects or reactions that concern you. LUNESTA, like most sleep medicines, carries some risk of dependency. Side effects may include unpleasant taste, headache, morning drowsiness and dizziness.

INDICATION
Lunesta® (eszopiclone) is a prescription sleep medicine used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include trouble falling asleep and waking up often during the night.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For more information, please see the LUNESTA Medication Guide and Full Prescribing Information.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. The products discussed herein may have different product labeling in different countries. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient. Remember that no medicine is for everyone. Only your healthcare professional can prescribe LUNESTA for you.

This site is intended for U.S. residents 18 years of age or older.