Rozerem Oral

Uses

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).

How to use Rozerem Oral

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.

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; use caution engaging in activities requiring alertness such as driving or using machinery. 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.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

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.

NOTES:

Do not share this medication with others. Laboratory tests (e.g., hormone levels) may be performed if you have certain side effects. Consult your doctor for more details.

Lifestyle changes that can help you get to sleep include reducing stress, not smoking, avoiding caffeine and alcoholic beverages for at least 4 to 6 hours before bedtime, listening to relaxing music, and doing relaxation exercises. Get up and go to bed at the same time each day. Don't take naps during the day, and make sure your bedroom is quiet and comfortable.

MISSED DOSE:

Not applicable.

STORAGE:

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.

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.

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.

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, thoughts of harming oneself).

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, 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.

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.