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.

ZALEPLON - ORAL

(ZAL-e-plon)

COMMON BRAND NAME(S): Sonata

USES: This medication is used for a short time to treat people who have trouble falling asleep. If you have other sleep problems such as not being able to sleep through the night, this medication may not be right for you. Zaleplon is known as a hypnotic. It works on certain centers in the brain to relax you and help you fall asleep faster.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking zaleplon and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth as directed by your doctor. Zaleplon works very quickly, so it is important to take it just before or when you get into bed. Zaleplon should not be used for naps or short sleep periods of less than 4 hours because this may increase your risk of side effects such as memory loss or drowsiness. Your doctor will work with you to find the smallest dose that works for you. You should not eat a very heavy/high-fat meal within 2 hours before taking this medication since doing so may prevent the drug from working properly. Dosage is based on your medical condition and response to therapy. Since this medication is usually prescribed for a short time, your doctor will tell you when to stop taking it or when to cut back. You may feel anxious or have trouble falling asleep in the first day or two after stopping this medication (rebound insomnia). Contact your doctor if you continue to have trouble falling asleep several days after stopping zaleplon. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time (more than a few weeks) or in high doses. In such cases, withdrawal symptoms (such as unusual depressed/anxious mood, stomach/muscle cramps, vomiting, sweating, shakiness, or seizures) 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 time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted. Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Dizziness, drowsiness, short-term memory loss, or lack of coordination may occur, especially during the first 2 hours after you take the medication. Taking the medication properly just before falling asleep will reduce your risk of these effects. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. 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., agitation, seeing/hearing things that are not there, rare thoughts of suicide), unusual behavior. 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 zaleplon. 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 zaleplon, 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. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, very high/low blood pressure, breathing problems (e.g., asthma), depression, history of drug/alcohol abuse. 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. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Before having surgery, tell your doctor or dentist that you are using this medication. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of this drug, especially memory problems. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This medication passes into breast milk and may have undesirable effects on a nursing infant. 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 them. 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 zaleplon. Tell your doctor of all prescription and nonprescription medication you may use, especially of: melatonin, drugs affecting liver enzymes that remove zaleplon from your body (e.g., azole antifungals such as ketoconazole, cimetidine, rifamycins such as rifabutin/rifampin, certain anti-seizure medicines such as phenytoin, carbamazepine, phenobarbital). Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine, promethazine), anti-seizure drugs (e.g., levetiracetam), other drugs for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants (e.g., cyclobenzaprine, carisoprodol), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., thioridazine, risperidone, amitriptyline, trazodone). 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, loss of coordination, slow/shallow breathing, and loss of consciousness.

NOTES: Do not share this medication with others. It is against the law. 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: Not applicable.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) in a light-blocking container away from light and moisture. 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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