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.

LUNESTA® (eszopiclone) FAQs

It's important to learn about a prescription medication before you start taking it. If you have questions that are not answered here, be sure to ask your healthcare professional.

About LUNESTA

I've never taken a sleep aid before. Why should I now?

Sleep helps the body recharge and may have an impact on your health. If you've been experiencing difficulty sleeping for more than a few weeks, talk to your healthcare professional about your sleep and if a sleep aid like LUNESTA may be right for you.

What is LUNESTA?

LUNESTA is a sedative-hypnotic (sleep) medicine. LUNESTA is 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.

LUNESTA is not for children under the age of 18.

How does LUNESTA work?

The exact way LUNESTA works is unknown, but it is thought to interact with GABA receptors. GABA — gamma-aminobutyric acid — is one of the most important chemicals associated with sleep. See How LUNESTA May Work.

Before prescribing LUNESTA, what will my healthcare professional need to know?

It's important to tell your healthcare professional about your specific symptoms, and how long you've had them. Get a Doctor Discussion Guide. Share a list of all your medications (prescription and otherwise], vitamins and supplements. Your healthcare professional will want to know if you have a history of depression, mental illness, suicidal thoughts, drug/alcohol abuse or addiction. You should also tell your healthcare professional if you have liver disease or are pregnant, planning to become pregnant or breastfeeding.

Are there any savings offers to help reduce my out-of-pocket expenses?

Yes. The LUNESTA® Rest For Less™ Savings Program — a $0 co-pay reduction card program. The LUNESTA® Rest For Less™ Savings Program provides most LUNESTA patients with their prescription for as low as $0 by saving them up to $50 on each of their next 12 prescription fills each calendar year. See offer details and terms and conditions.

While there are restrictions to joining the program, it is not restricted to household income. You can save on your co-pay costs if you pay for your prescriptions out of pocket. Please note that co-pay amounts may vary.

Taking LUNESTA

Who should and should not take LUNESTA?

LUNESTA is for adults with insomnia. If you are having trouble falling or staying asleep, you should ask your healthcare professional if LUNESTA is right for you.

Do not take LUNESTA if you are allergic to anything it contains. Check the LUNESTA Medication Guide for a list of the ingredients. As with all medications, LUNESTA has side effects, so be sure to speak with your healthcare professional about the potential benefits and risks. Before starting LUNESTA, tell your healthcare professional about all of your health conditions, including if you:

  • Take other medications that can make you sleepy
  • Have a history of depression, mental illness or suicidal thoughts
  • Have a history of drug or alcohol abuse or addiction
  • Have liver disease
  • Are pregnant, planning to become pregnant or breastfeeding

How do I take LUNESTA?

Only take LUNESTA as directed by your healthcare professional. You should swallow the pill right before bed with water, never alcohol. You should only take LUNESTA if you have 8 hours to devote to sleep.

Can I take LUNESTA with food or alcohol?

No. For LUNESTA to work best, you should not take it with or right after a heavy meal. You should never drink alcohol with LUNESTA, as it can increase the side effects. As with all medications, you should take LUNESTA only as directed by your healthcare professional.

Can I take LUNESTA if I'm on other medications or a sleep aid?

Before taking LUNESTA with any medication, including over-the-counter (OTC) or herbal remedies, or making any changes to your treatment plan, you should talk with your healthcare professional. Other medications may cause harmful interactions. Do not take LUNESTA with any other sleep aid or medications that can make you sleepy.

What are the available doses for LUNESTA?

LUNESTA is available in 1-, 2-, and 3-mg tablets. Your healthcare professional can tell you which starting dose is right, depending on your age, health and specific sleep problem. As with any sleep medication, you shouldn't change your dose before talking to your healthcare professional.

If I start taking LUNESTA, do I have to take it every night?

LUNESTA should be taken only as prescribed by your healthcare professional. Some people take LUNESTA on a short-term, "as-needed" basis, while others with chronic sleep issues take it as long as needed. You and your healthcare professional will develop a sleep plan that works for your individual needs.

How should I store LUNESTA?

Store LUNESTA at room temperature, between 59°F to 86°F (15°C to 30°C]. Do not use LUNESTA after the expiration date. Keep LUNESTA and all medicines out of reach of children.

Effects of LUNESTA

How will I feel the day after I take LUNESTA?

Some patients may still feel drowsy the next morning after taking LUNESTA. Do not drive or do other dangerous activities after taking LUNESTA until you feel fully awake.

Can I become dependent on LUNESTA?

LUNESTA, like most sleep medicines, carries some risk of dependency. People who have been dependent on alcohol or other drugs in the past may have a higher chance of becoming dependent on sleep medicines.

What are the side effects of LUNESTA?

In clinical studies, the most common side effects people taking LUNESTA had were an unpleasant taste in the mouth, dry mouth, morning drowsiness, dizziness, headache and symptoms of the common cold.

Possible serious side effects of LUNESTA include:

  • Sleepiness during the day
  • Getting out of bed while not being fully awake and doing an activity that you do not know you are doing. (See "What is the most important information I should know about LUNESTA?" in 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.

Call your healthcare professional right away if you have any of the above side effects or any other side effects that worry you while taking LUNESTA.

What if I experience a bad taste?

Some people experience an unpleasant taste after taking LUNESTA. Here are some simple things you can try. These suggestions have not been studied, but they may work for you:

  • Drink a full glass of water when you take it.
  • 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 this or any other side effect that concerns 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.

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.