Brand Rozerem

This medication is used to treat sleeplessness (insomnia). It helps you fall asleep faster so you can get a full night's rest. Sleep is important for your ability to function, think clearly, and remain alert. Lack of sleep can cause problems such as depression, heart disease and accidents. Getting enough sleep allows your mind and body to repair itself and increases your energy throughout the day. Ramelteon works like a natural substance called melatonin that is produced by your body. It helps regulate your sleep-wake cycle (circadian rhythm).

Read the Medication Guide provided by your pharmacist before you start taking ramelteon and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food, 30 minutes before bedtime, or as directed by your doctor. Do not take ramelteon with or immediately after a high-fat meal because fat can affect how well this drug works. The manufacturer directs not to split/crush the tablet before taking it. However, many similar drugs (immediate-release tablets) can be split/crushed. Follow your doctor's directions on how to take this medication. Do not take a dose of this medication unless you have time for a full night's sleep that lasts at least 7 to 8 hours. Your dosage is based on your medical condition and response to therapy. Do not increase your dose or take it more frequently than prescribed. Inform your doctor if you have any changes in mood (e.g., feelings of depression), if you continue to have trouble falling asleep, or if your insomnia worsens.

Before taking ramelteon, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: severe liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (bronchitis, emphysema, sleep apnea), liver disease. 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 because they may increase the risk of this drug's side effects and can worsen sleeping problems. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

Not applicable.

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: fluvoxamine. If you are currently using the medication listed above, tell your doctor or pharmacist before starting ramelteon. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs affecting liver enzymes that remove ramelteon from the body such as azole antifungals (e.g., ketoconazole, fluconazole) and rifamycins (e.g., rifampin). Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, 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.

Dizziness, tiredness, or daytime drowsiness may occur. 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. Some people who take sleep medications have reported getting out of bed and sleep-walking, driving, eating, talking on the phone, or doing other activities while not fully awake. Often, they have no memory of these activities. This problem can be dangerous to you or others. If you have or think you have this problem, tell your doctor immediately. Your risk is increased if you use alcohol or other medications that can make you drowsy. Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased sexual desire, missed menstrual periods, nipple discharge, difficulty becoming pregnant. Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes (e.g., depression, strange thoughts, thoughts of suicide). A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

Store 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. Keep container tightly closed. 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.