IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ESZOPICLONE - ORAL

(es-zoe-PIK-lone)

COMMON BRAND NAME(S): Lunesta

USES: This medication is used to treat sleep problems (insomnia). It may help you fall asleep faster, sleep better during the night, and stay asleep longer. Eszopiclone belongs to a class of drugs known as hypnotics.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using eszopiclone and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Take this medication by mouth usually once nightly, immediately before going to bed, or as directed by your doctor. Do not take it with or immediately after a high-fat or heavy meal. Although unlikely, this drug can infrequently cause temporary memory loss. To avoid this effect, do not take a dose of this drug unless you have time for a full night's sleep that lasts at least 7-8 hours. For example, do not take this drug during an overnight plane flight of less than 8 hours. Dosage is based on your medical condition, age, and response to therapy. Take the exact dose for the duration prescribed by your doctor. Do not change your dose without talking to your doctor. The manufacturer does not recommend doses above 2 milligrams if you have severe liver disease. Consult your doctor or pharmacist if you have any questions about your treatment. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, abdominal cramps, vomiting, sweating, or shakiness) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit-forming). Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted. You may have trouble falling asleep the first few nights after you stop taking the drug. This is called rebound insomnia. It is normal and usually goes away after 1-2 nights. If this effect continues, contact your doctor. Inform your doctor if your sleep problems persist or worsen after 7 to 10 days.

SIDE EFFECTS: Drowsiness, dizziness, dry mouth, headache, and unpleasant taste may occur. To minimize the risk of falls, remember to get up slowly when rising from a seated or lying position. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., worsening depression, hallucinations, agitation, or rare thoughts of suicide), memory problems, loss of coordination, signs of infection (e.g., fever, chills, persistent sore throat). Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor immediately. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking eszopiclone. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives). Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, lung diseases (e.g., chronic obstructive pulmonary disease, sleep apnea), mental/mood problems (e.g., depression), personal or family history of regular use/abuse of drugs/alcohol/other substances. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially drowsiness and dry mouth. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who take this medication near the time of delivery may have undesirable effects such as excessive sleepiness. Tell your doctor if you notice such effects in your newborn. It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. This drug should not be used with the following medication because very serious interactions may occur: sodium oxybate. If you are currently using the medication listed above, tell your doctor or pharmacist before starting eszopiclone. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs affecting enzymes that remove this medication from your body (e.g., azole antifungals such as ketoconazole and itraconazole, macrolide antibiotics such as clarithromycin, nefazodone, certain HIV medications such as ritonavir and nelfinavir, rifampin). Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: antihistamines that cause drowsiness (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., carbamazepine), muscle relaxants (e.g., cyclobenzaprine, methocarbamol), narcotic pain relievers (e.g., codeine), other medicines for sleep (e.g., zolpidem), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), tranquilizers. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: confusion, fainting, or a deep sleep from which you cannot be awakened.

NOTES: Do not share this medication with others. It is against the law. This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in those cases. Usually, insomnia is temporary and requires sleep medication only for a short time. If you require treatment for more than 7-10 days, laboratory and/or medical tests may be performed to find other causes of your sleep problems. Lifestyle changes may help improve your sleep (e.g., avoid drinking beverages containing caffeine close to bedtime or taking daytime naps). Consult your doctor or pharmacist for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember if it is still near bedtime and you have trouble falling asleep. If it is already the next day, resume your usual dosing schedule that night at bedtime. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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