Ramelteon (By mouth)
Treats insomnia (trouble falling asleep).
RozeremThere may be other brand names for this medicine.
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. This medicine does not treat sleep disorders that are caused by depression or mental illness.
How to Use This Medicine:
- 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 activity besides getting ready for bed.
- Do not take this medicine with or right after a meal.
- Swallow the tablet whole. Do not break 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. Your doctor might ask you to sign some forms to show that you understand this information.
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 leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
- 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 rifampin (Rifadin®, Rimactane®), ketoconazole (Nizoral®), or fluconazole (Diflucan®).
- 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, mental illness, or 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, or mouth when you take this medicine.
- 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. This medicine may also cause sleep-related behaviors such as sleep-driving, sleep-walking, having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.
- 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 your menstrual periods.
- Depressed mood, thoughts of hurting yourself.
- Discharge from your nipples (in women).
- Loss of interest in sex.
- Unusual thoughts or behavior.
If you notice these less serious side effects, talk with your doctor:
- Bad or unusual taste in your mouth.
- Feeling tired during the day.
- Muscle or joint pain.
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
Last Updated: 1/4/2011
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