When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to ramelteon, if you are also using fluvoxamine (Luvox®), or if you have severe liver disease.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine no more than 30 minutes before you go to bed. After you take the medicine, do not engage in any other activity except getting ready for bed.
• Do not take this medicine with or right after a high-fat meal.
• Swallow the tablet whole. Do not break, crush, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using donepezil (Aricept®), doxepin (Sinequan®), fluconazole (Diflucan®), ketoconazole (Nizoral®), or rifampin (Rifadin®, Rimactane®).
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, sleep apnea, or a breathing disorder such as COPD (chronic obstructive pulmonary disease). Tell your doctor if you have a history of depression or mental illness, or if you have ever had thoughts of hurting yourself.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching, hives, trouble breathing, or any swelling of your hands, face, mouth, or tongue when you take this medicine.
• You might have mood or behavior changes with this medicine, such as feeling sad or hopeless, or getting upset easily. You could feel nervous or hostile. Some people become violent and want to hurt themselves or others. You might have too much energy, or see or hear unusual things. Call your doctor right away if you have any strange feelings, thoughts, or behaviors.
• This medicine may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while you are asleep or not fully awake. If these unwanted effects occur, tell your doctor right away.
• This medicine may cause some hormone changes. Talk to your doctor if you have any of these symptoms: a decreased interest in sex; problems getting pregnant; an irregular or change in menstrual periods; or discharge from the nipples (in women).
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Call your doctor if your symptoms do not improve or if they get worse.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in behavior or thoughts of hurting yourself or others.
• Changes in menstrual periods.
• Discharge from the nipples in women.
• Feeling depressed, anxious, or agitated.
• Loss of interest in sex.
• Seeing, hearing, or feeling things that are not there.
• Unusual thoughts or behavior.
• Unusual tiredness or weakness.
• Worsening of insomnia (trouble sleeping).

If you notice these less serious side effects, talk with your doctor:

• Dizziness or drowsiness.
• Headaches.
• Nausea.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088