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Drug Rozerem

Pronunciation: ra-MEL-tee-on

Generic Name: Ramelteon

Brand Name: Rozerem

Rozerem is used for:

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 you fall asleep.

Do NOT use Do NOT use Rozerem if:

  • you are allergic to any ingredient in Rozerem

  • 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.

    Before using 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, 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 Rozerem. 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 Rozerem's side effects

  • Rifampin because it may decrease Rozerem's effectiveness

  • 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 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.

  • Swallow Rozerem whole. Do not break, crush, or chew before swallowing.

  • Use Rozerem only when you are able to get a full night's sleep (7 to 8 hours).

  • After you take Rozerem, limit your activities to those necessary to prepare for bed.

  • If you miss a dose of Rozerem, 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 Important safety information:

  • Rozerem may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Rozerem 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 Rozerem; 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 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.

  • Possible side effects 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; 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 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 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 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.

  • Check with your pharmacist about how to dispose of unused medicine.

  • 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.

    Drugs: Rozerem

    Category: R

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