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Generic Name: Ramelteon (ram-EL-tee-on)
Brand Name: Rozerem

Ramelteon is used for:

Treating insomnia. 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]), mental or mood problems (eg, depression), or 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 side effects of Ramelteon may be increased
  • Rifampin because its effectiveness may be decreased

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 may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Do not take Ramelteon with or immediately after a high-fat meal.
  • Take Ramelteon within 30 minutes prior to going to bed.
  • 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.
  • Ramelteon is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Ramelteon , discuss with your doctor the benefits and risks of using Ramelteon during pregnancy. It is unknown if Ramelteon is excreted 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; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); absence of a menstrual cycle; decreased sex drive; fever; hallucinations; headache; irregular heartbeat; mental or mood changes; muscle aches; muscle or joint pain; pounding in the chest; problems with fertility; suicidal thoughts or behaviors; unexplained breast milk production; vision changes; worsening of depression; worsening of sleeplessness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), 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.

General information:

  • 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.

Issue Date: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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