Ramelteon Generic Name:
Ramelteon (ra-MEL-tee-on)Brand Name:
Ramelteon is used for:
Treating insomnia (trouble falling asleep). It may also be used for other conditions as determined by your doctor.
Ramelteon in a melatonin agonist. It works by acting on the melatonin receptors in the brain, which helps cause sleep.
Do NOT use Ramelteon if:
- you are allergic to any ingredient in Ramelteon
- you have severe liver problems
- you are taking fluvoxamine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Ramelteon :
Some medical conditions may interact with Ramelteon . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver problems, heart disease, difficulty breathing while sleeping, severe lung problems (eg, chronic obstructive pulmonary disease [COPD]), or mental or mood problems (eg, depression), or if you have a history of alcohol abuse or suicidal thoughts or behaviors
Some MEDICINES MAY INTERACT with Ramelteon . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Fluvoxamine or imidazoles (eg, ketoconazole) because the risk of Ramelteon 's side effects may be increased
- Rifampin because its effectiveness may be decreased by Ramelteon
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ramelteon may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Ramelteon :
Use Ramelteon as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ramelteon comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ramelteon refilled.
- Do not take Ramelteon with or immediately after a high-fat meal.
- Take Ramelteon by mouth within 30 minutes prior to going to bed.
- Use Ramelteon only when you are able to get a full night's sleep (7 to 8 hours).
- If your insomnia worsens or is not better within 7 to 10 days, check with your doctor. This may mean there is another condition causing your sleep problems.
- If you miss a dose of Ramelteon and you are taking 1 dose daily at bedtime, skip the missed dose. Do not take the dose in the morning or take 2 doses at once.
Ask your health care provider any questions you may have about how to use Ramelteon .
Important safety information:
- Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ramelteon . Using Ramelteon alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Ramelteon . Ramelteon will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
- When you first start taking Ramelteon , it may have a "carryover" effect on you the next day. Use extreme care while doing anything that requires complete alertness (eg, driving a car).
- Some patients taking Ramelteon have performed certain activities while they were not fully awake. These have included sleep-driving, making and eating food, making phone calls, and having sex. Patients often do not remember these events after they happen. Such an event may be more likely to occur if you use a high dose of Ramelteon . It may also be more likely if you drink alcohol or take other medicines that may cause drowsiness while you use Ramelteon . Tell your doctor right away if such an event happens to you.
- Ramelteon should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ramelteon while you are pregnant. It is not known if Ramelteon is found in breast milk. Do not breast-feed while taking Ramelteon .
When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as TOLERANCE. Sleep medicines should usually be used only for short periods of time, such as a few days and generally no longer than 1 or 2 weeks. If your sleep problems continue, contact your doctor.
Possible side effects of Ramelteon :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; dizziness; drowsiness; fatigue; nausea; tiredness.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, legs, mouth, face, lips, eyes, throat, or tongue; unusual hoarseness); absence of a menstrual cycle; decreased sex drive; difficulty swallowing or breathing; fever; hallucinations; headache; irregular heartbeat; memory problems; mental or mood changes (eg, abnormal thinking, agitation, anxiety, behavior changes, new or worsening depression); muscle aches; muscle or joint pain; pounding in the chest; problems with fertility; shortness of breath; suicidal thoughts or behaviors; unexplained breast milk production; vision changes; vomiting; worsening of sleeplessness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Ramelteon :
Store Ramelteon at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ramelteon out of the reach of children and away from pets.
- If you have any questions about Ramelteon , please talk with your doctor, pharmacist, or other health care provider.
- Ramelteon is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Ramelteon . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Ramelteon Professional Patient Advice (Wolters Kluwer)
- Ramelteon Detailed Consumer Information (PDR)
- ramelteon Advanced Consumer (Micromedex) - Includes Dosage Information
- Rozerem Prescribing Information (FDA)
- Rozerem Consumer Overview