Lunesta is a sedative, also called a hypnotic. It affects chemicals in your brain that may be unbalanced in people with sleep problems (insomnia).

Lunesta is used to treat insomnia.

Lunesta causes relaxation to help you fall asleep and stay asleep.

Lunesta may cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Lunesta will make you fall asleep. Never take this medication during your normal waking hours, unless you have at least 8 hours to dedicate to sleeping.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Lunesta and talk with your doctor about another treatment for your sleep disorder.

Lunesta can cause sie effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Do not drink alcohol while you are taking this medication. It can increase some of the side effects, including drowsiness. Eszopiclone may be habit-forming and should be used only by the person it was prescribed for. Lunesta should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

You may have withdrawal symptoms if you stop taking this medication after taking it over several days in a row. Do not stop taking this medicine suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Take Lunesta exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Eszopiclone may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Lunesta will make you fall asleep. Never take this medicine during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping.

Call your doctor if your symptoms do not improve after 7 to 10 days of treatment, or if they get worse.

Do not stop using Lunesta suddenly after taking it over several days in a row, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Insomnia symptoms may also return after you stop taking Lunesta, and may be even worse than before. Tell your doctor if you still have worsened insomnia after the first few nights without taking Lunesta.

Usual Adult Dose for Insomnia:

Initial dose: 1 mg orally once a day immediately before bedtime
Maintenance dose: 1 to 3 mg orally once a day immediately before bedtime
Maximum dose: 3 mg/day

Comments:
-The lowest effective dose should be used.
-Patients should be monitored for cognitive and/or motor impairments, especially if this drug is used repeatedly.
-Patients should be reevaluated if insomnia persists after 7 to 10 days of treatment.

Usual Geriatric Dose for Insomnia:

Initial dose: 1 mg orally once a day immediately before bedtime
Maintenance dose: 1 to 2 mg orally once a day immediately before bedtime
Maximum dose: 2 mg/day

Comments:
-The lowest effective dose should be used.
-Patients should be monitored for cognitive and/or motor impairments, especially if this drug is used repeatedly.
-Patients should be reevaluated if insomnia persists after 7 to 10 days of treatment.

You should not use Lunesta if you are allergic to eszopiclone, or if you have ever taken sleep medicine and engaged in activity you later don't remember.

Lunesta is not approved for use by anyone younger than 18 years old.

To make sure Lunesta is safe for you, tell your doctor if you have ever had:

• liver disease;

• a breathing disorder;

• depression, mental illness, or suicidal thoughts; or

• drug or alcohol addiction.

Tell your doctor if you are pregnant or breast-feeding.

The sedative effects of eszopiclone may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking Lunesta.

Since Lunesta is taken only at bedtime, you will not be on a frequent dosing schedule. Never take this medicine if you do not have at least 7 to 8 hours to sleep before being active again.

Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of eszopiclone can be fatal, especially when it is taken together with other medications that can cause drowsiness.

Avoid taking Lunesta during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get at least 8 hours of sleep after taking Lunesta.

Avoid drinking alcohol. Dangerous side effects or death could occur.

Avoid taking eszopiclone within 1 hour after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medication.

Eszopiclone can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. Until you know how this medicine will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Eszopiclone may cause a severe allergic reaction. Stop taking Lunesta and get emergency medical help if you have signs of an allergic reaction to Lunesta: hives; nausea, vomiting; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, or making phone calls. If this happens to you, stop taking Lunesta and call your doctor right away.

Serious injury or death could occur if you walk or drive while you are not fully awake.

Call your doctor at once if you have:

• anxiety, depression, aggression, agitation;

• memory problems, unusual thoughts or behavior;

• thoughts of hurting yourself; or

• confusion, hallucinations (hearing or seeing things).

Common Lunesta side effects may include:

• day-time drowsiness, dizziness, "hangover" feeling;

• headache, anxiety;

• dry mouth;

• unusual or unpleasant taste in your mouth;

• rash; or

• cold or flu symptoms such as fever, body aches, sore throat, cough, runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Lunesta with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, other sleep medicine, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with eszopiclone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.