Eszopiclone (patient information)

IMPORTANT WARNING
[Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify them about the new warnings, and that manufacturers develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken.

Why this medication is prescribed
Eszopiclone is used to treat insomnia (difficulty falling asleep or staying asleep). Eszopiclone is in a class of medications called hypnotics. It works by slowing activity in the brain.

How this medication should be used
Eszopiclone comes as a tablet to take by mouth. It is usually taken once a day at bedtime. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take eszopiclone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not take eszopiclone with or shortly after a heavy, high-fat meal. Eszopiclone may not work well if it is taken with high fat foods.

You will probably become very sleepy soon after you take eszopiclone and will remain sleepy for some time after you take the medication. Plan to go to bed right after you take eszopiclone, and to stay in bed for at least 8 hours. If you do not go to bed right after you take eszopiclone or if you get up too soon after taking eszopiclone, you may experience dizziness, lightheadedness, hallucinations (seeing things or hearing voices that do not exist), and problems with coordination and memory.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor may start you on a low dose of eszopiclone and gradually increase your dose.Your doctor may also decrease your dose if you are too drowsy during the daytime.

You should be sleeping well within 7 to 10 days after you start taking eszopiclone. Call you doctor if your sleep problems do not improve during this time or if they get worse at any time during your treatment.

Do not stop taking eszopiclone without talking to your doctor, especially if you have taken it for longer than 1-2 weeks. Your doctor will probably decrease your dose gradually. If you suddenly stop taking eszopiclone you may experience withdrawal symptoms such as anxiety, unusual dreams, stomach and muscle cramps,upset stomach, vomiting, sweating, shakiness, and, rarely, seizures.

After you stop taking eszopiclone, you may have more difficulty falling asleep and staying asleep than you did before you took the medication. These sleep problems are normal and usually get better without treatment after one or two nights.

Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions
Before taking eszopiclone:


 * tell your doctor and pharmacist if you are allergic to eszopiclone or any other medications.
 * tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); antidepressants ('mood elevators'); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); antihistamines; carbamazepine (Tegretol); cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); dexamethasone (Decadron); diltiazem (Cardizem, Dilacor, Tiazac); ethosuximide (Zarontin); erythromycin (E.E.S., E-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as indinavir (Crixivan) nelfinavir (Viracept), and ritonavir (Norvir); isoniazid (INH, Nydrazid); medications for anxiety, mental illness, or seizures; metronidazole (Flagyl); nefazodone; olanzapine (Zyprexa); oral contraceptives (birth control pills); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); sedatives; sleeping pills; tranquilizers; troglitazone (Rezulin); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
 * tell your doctor what herbal products you are taking, especially St. John's wort.
 * tell your doctor if you drink or have ever drunk large amounts of alcohol and if you use or have ever used street drugs or have overused prescription medications. Also tell your doctor if you have ever thought about killing yourself or tried to do so and if you have or have ever had any medical condition especially depression, mental illness, asthma, chronic obstructive pulmonary disease (COPD, a group of diseases that affect the lungs and airways), any other condition that affects your breathing, or liver disease.
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking eszopiclone, call your doctor.
 * if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking eszopiclone.
 * you should know that eszopiclone may make you drowsy during the daytime. Do not drive a car or operate machinery until you know how this medication affects you.
 * do not drink alcoholic beverages while you are taking eszopiclone. Alcohol can make the side effects from eszopiclone worse.
 * you should know that your mental health may change in unexpected ways while you are taking this medication. These changes may be caused by eszopiclone or if they may be caused by physical or mental illnesses that you already have or that you develop during your treatment. *Tell your doctor right away if you experience any of the following symptoms: aggressiveness, strange or unusually outgoing behavior, hallucinations (seeing things or hearing voices that do not exist), feeling as if you are outside of your body, memory problems, new or worsening depression, thinking about killing yourself, confusion, and any other changes in your usual thoughts or behavior. Be sure that your family knows which symptoms may be serious so that they can call the doctor if you are unable to seek treatment on your own.

Before taking eszopiclone:


 * tell your doctor and pharmacist if you are allergic to eszopiclone or any other medications.
 * tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); antidepressants ('mood elevators'); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); antihistamines; carbamazepine (Tegretol); cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); dexamethasone (Decadron); diltiazem (Cardizem, Dilacor, Tiazac); ethosuximide (Zarontin); erythromycin (E.E.S., E-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as indinavir (Crixivan) nelfinavir (Viracept), and ritonavir (Norvir); isoniazid (INH, Nydrazid); medications for anxiety, mental illness, or seizures; metronidazole (Flagyl); nefazodone; olanzapine (Zyprexa); oral contraceptives (birth control pills); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); sedatives; sleeping pills; tranquilizers; troglitazone (Rezulin); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
 * tell your doctor what herbal products you are taking, especially St. John's wort.
 * tell your doctor if you drink or have ever drunk large amounts of alcohol and if you use or have ever used street drugs or have overused prescription medications. Also tell your doctor if you have ever thought about killing yourself or tried to do so and if you have or have ever had any medical condition especially depression, mental illness, asthma, chronic obstructive pulmonary disease (COPD, a group of diseases that affect the lungs and airways), any other condition that affects your breathing, or liver disease.
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking eszopiclone, call your doctor.
 * if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking eszopiclone.
 * you should know that eszopiclone may make you drowsy during the daytime. Do not drive a car or operate machinery until you know how this medication affects you.
 * do not drink alcoholic beverages while you are taking eszopiclone. Alcohol can make the side effects from eszopiclone worse.
 * you should know that your mental health may change in unexpected ways while you are taking this medication. These changes may be caused by eszopiclone or if they may be caused by physical or mental illnesses that you already have or that you develop during your treatment. *Tell your doctor right away if you experience any of the following symptoms: aggressiveness, strange or unusually outgoing behavior, hallucinations (seeing things or hearing voices that do not exist), feeling as if you are outside of your body, memory problems, new or worsening depression, thinking about killing yourself, confusion, and any other changes in your usual thoughts or behavior. Be sure that your family knows which symptoms may be serious so that they can call the doctor if you are unable to seek treatment on your own.

Special dietary instructions
Talk to your doctor about drinking grapefruit juice while taking this medication

What to do if you forget a dose
Eszopiclone should only be taken at bedtime. If you did not take eszopiclone before you went to bed and you are unable to fall asleep, you may take eszopiclone if you will be able to stay in bed for at least 8 hours afterward. Do not take eszopiclone if you are not ready to go to sleep right away and stay asleep for at least 8 hours. Do not take a double dose of eszopiclone to make up for a missed dose.

Minor side effects
Eszopiclone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:


 * unpleasant taste
 * headache
 * cold-like symptoms
 * pain
 * daytime drowsiness
 * lightheadedness
 * dizziness
 * loss of coordination
 * upset stomach
 * vomiting
 * heartburn
 * unusual dreams
 * decreased sexual desire
 * painful menstruation (periods)
 * breast enlargement in males

Severe side effects
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:


 * rash
 * itching
 * chest pain
 * swelling of the hands, feet, ankles, or lower legs
 * painful or frequent urination
 * bloody or cloudy urine
 * back pain

Eszopiclone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:


 * drowsiness
 * loss of consciousness
 * coma

Other information
Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

 * Lunesta®