Ramelteon (By mouth)

Introduction

Ramelteon (ra-MEL-tee-on)

Treats insomnia (trouble falling asleep).

Brand Name(s)

Rozerem

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• 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. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you forget to take your medicine at bedtime and you cannot sleep, take it as soon as you remember the missed dose. If it is almost time for you to awaken, skip the missed dose and wait until the next night to take your medicine. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

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 are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• 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.
• If your symptoms do not improve or if they get worse, call your doctor.

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