Consumer Drug Information

Rozerem


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

Rozerem is used for:

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

Rozerem in a melatonin agonist. It works by acting on the melatonin receptors in the brain, which helps cause sleep.

Do NOT use Rozerem if:

  • you are allergic to any ingredient in Rozerem
  • 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 Rozerem :

Some medical conditions may interact with Rozerem . 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 Rozerem . 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 Rozerem 's side effects may be increased
  • Rifampin because its effectiveness may be decreased by Rozerem

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rozerem 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 Rozerem :

Use Rozerem as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Rozerem comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Rozerem refilled.
  • Do not take Rozerem with or immediately after a high-fat meal.
  • Take Rozerem by mouth within 30 minutes prior to going to bed.
  • Use Rozerem 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 Rozerem 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 Rozerem .

Important safety information:

  • Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Rozerem . Using Rozerem 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 Rozerem . Rozerem 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 Rozerem , 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 Rozerem 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 Rozerem . It may also be more likely if you drink alcohol or take other medicines that may cause drowsiness while you use Rozerem . Tell your doctor right away if such an event happens to you.
  • Rozerem 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 Rozerem while you are pregnant. It is not known if Rozerem is found in breast milk. Do not breast-feed while taking Rozerem .

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 Rozerem :

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 Rozerem :

Store Rozerem 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 Rozerem out of the reach of children and away from pets.

General information:

  • If you have any questions about Rozerem , please talk with your doctor, pharmacist, or other health care provider.
  • Rozerem 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 Rozerem . 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 4, 2009
Database Edition 09.4.1.002
Copyright © 2009 Wolters Kluwer Health, Inc.



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