Lunesta

Lunesta is a prescription medication used to treat insomnia (difficulty falling or staying asleep). Lunesta belongs to a group of drugs called hypnotics. It works by slowing brain activity to allow you to sleep.

This medication comes in tablet form and is taken once daily, immediately before bedtime.

Common side effects include unpleasant taste, dry mouth, and dizziness.

Lunesta is a prescription medication used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:

• trouble falling asleep
• waking up often during the night

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sunovion Pharmaceuticals Inc.

Possible serious side effects include:

• getting out of bed while not being fully awake and do an activity that you do not know you are doing (see "Drug Precautions").
• 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 eszopiclone.

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using Lunesta.

The most common side effects of Lunesta are:

• unpleasant taste in mouth, dry mouth
• drowsiness
• dizziness
• headache
• symptoms of the common cold

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

These are not all the side effects of Lunesta. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• olanzapine
• ketoconazole
• itraconazole
• rifampin
• antidepressants
• antihistamines
• other sleeping pills
• antibiotics (Biaxin)
• nelfinavir (Viracept)
• ritonavir (Norvir)
• antianxiety medicines
• seizure medicines

Medicines can interact with each other, sometimes causing serious side effects. Do not take Lunesta with other medicines that can make you sleepy. This is not a complete list of medicines that can interact with Lunesta. Ask your doctor or pharmacist for a complete list.

After taking Lunesta, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Lunesta. Reported activities include:

• driving a car ("sleep-driving")
• making and eating food
• talking on the phone
• having sex
• sleep-walking

Call your doctor right away if you find out that you have done any of the above activities after taking Lunesta.

Important:

1. Take Lunesta exactly as prescribed
   • Do not take more Lunesta than prescribed.
   • Take eszopiclone right before you get in bed, not sooner.
2. Do not take Lunesta if you:
   • drink alcohol
   • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take Lunesta with your other medicines
   • cannot get a full night's sleep

Do not take Lunesta if you are allergic to anything in it.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Lunesta there are no specific foods that you must exclude from your diet when receiving this medication.

Before starting Lunesta, tell your doctor about all of your health conditions, including if you:

• 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

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take Lunesta with other medicines that can make you sleepy.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Lunesta falls into category C. There are no well-done studies that have been done in humans with this medication. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or planning to breastfeed.

It is not known if Lunesta crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Lunesta.

• Take Lunesta exactly as prescribed. Do not take more Lunesta than prescribed for you.
• Take Lunesta right before you get into bed.
• Do not take Lunesta with, or right after a high-fat meal.
• Do not take Lunesta unless you are able to get a full night's sleep before you must be active again.
• 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.
• If you take too much Lunesta or overdose, call your doctor or poison control center right away, or get emergency treatment.

Take Lunesta exactly as prescribed

• Do not take more Lunesta than prescribed.
• Take Lunesta right before you get in bed, not sooner.

Patients starting on Lunesta should take no more than 1 mg at bedtime. Doses can be increased to 2 mg or 3 mg if needed, but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness.

If you take too much Lunesta (more than the prescribed amount) call your local Poison Control Center or seek emergency medical attention right away.

Lunesta tablets are available in the following strengths: 1 mg, 2 mg, and 3 mg.

• 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.