Ramelteon

Generic Name: ramelteon (ra-MEL-tee-on)
Brand Name: Rozerem

Ramelteon is used for:

Treating insomnia (trouble falling asleep). It may also be used for other conditions as determined by your doctor.

Ramelteon is a melatonin agonist. It works by acting on the melatonin receptors in the brain, which helps you fall asleep.

Do NOT use ramelteon if:

  • you are allergic to any ingredient in ramelteon
  • you have severe liver problems or severe sleep apnea
  • you are taking fluvoxamine

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Need To Catch Some Shut-Eye? Tips on Getting the Sleep You Need

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, lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD], sleep apnea), or mental or mood problems (eg, depression)
  • if you drink alcohol, 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:

  • Azole antifungals (eg, fluconazole, ketoconazole), doneprezil, doxeparin, or fluvoxamine because they may increase the risk of ramelteon's side effects
  • Rifampin because it may decrease ramelteon's effectiveness

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.
  • Swallow ramelteon whole. Do not break, crush, or chew before swallowing.
  • Use ramelteon only when you are able to get a full night's sleep (7 to 8 hours).
  • After you take ramelteon, limit your activities to those necessary to prepare for bed.
  • If you miss a dose of ramelteon, 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:

  • Ramelteon may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use ramelteon with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using ramelteon; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • If your insomnia does not get better within 7 to 10 days, check with your doctor. This may mean there is another condition causing your sleep problems.
  • 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.

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; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the hands, legs, mouth, face, lips, eyes, throat, or tongue; unusual hoarseness); absence of a menstrual cycle; decreased sexual desire; hallucinations; headache; memory problems; mental or mood changes (eg, abnormal thinking, agitation, anxiety, behavior changes, new or worsening depression); missed or irregular menstrual period; nausea; nightmares; nipple discharge; problems with fertility; shortness of breath; suicidal thoughts or behaviors; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ramelteon or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ramelteon. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ramelteon. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using ramelteon.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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