May 15, 2014FDA 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.
There is no way of knowing how your body will react to LUNESTA. If your insomnia gets worse or doesn't improve within 7 to 10 days, you should speak to your healthcare professional. There may be another condition that is disrupting your sleep patterns.
LUNESTA is contraindicated in patients with a known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema.
Guide to Taking LUNESTA
Here are some tips for taking LUNESTA.
Decide on a sleep plan with your healthcare professional and take LUNESTA only as prescribed.
Be sure to take LUNESTA with water right before bed.
LUNESTA should never be taken with alcohol.
Keep a Sleep Diary to understand more about your sleep patterns.
Only take LUNESTA if you have 8 hours to devote to sleep.
Some people experience an unpleasant taste after taking LUNESTA. Here are some simple suggestions that may work for you:
Drink a full glass of water when you take LUNESTA.
Swallow the pill immediately.
Take the pill whole, don't chew or crush it.
Drink orange juice or something acidic (except grapefruit juice) when you wake up.
Brush your teeth and tongue.
Use chewing gum or mouthwash.
If you experience any side effects that concern you, talk to your healthcare professional. 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. In addition, contact Sunovion Drug Safety and Adverse Events at 1-877-737-7226.
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.
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.
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