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.
If you toss and turn at night, you’re not alone. Approximately 20 million adults in the U.S. suffer from insomnia — a medical condition in which difficulty falling asleep and/or staying asleep have a negative impact on the next day. According to the National Sleep Foundation, symptoms of insomnia include:
Difficulty falling asleep
Waking up frequently during the night
Difficulty returning to sleep
Waking up too early in the morning
Effects of Insomnia
Insomnia shouldn’t be taken lightly. It is a serious medical condition that can affect your mind and body. We need plenty of sleep to rebuild and recharge, and without enough of it you may experience some or all of the following:
Decreased feelings of well-being
Decreased ability to concentrate
Decreased ability to problem solve
Difficulty in making decisions
The National Institutes of Health recommends that adults get 7–8 hours of sleep a night. If you're not getting enough sleep or experiencing any of these symptoms, you should make a plan to talk to your healthcare professional. It's important to seek treatment sooner rather than later.
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.
This site is intended for U.S. residents 18 years of age or older.