Generic Name: Ramelteon

  • What is this medication and its most common uses?

    Rozerem is a medicine used for the treatment of insomnia, specifically for people who have trouble falling asleep.

  • What should I know when beginning and continuing on this medication?

    How does this medication work?

    Rozerem works by decreasing the time it takes you to fall asleep.

    What are the beneficial effects of this medication and when should I begin to have results?

    What: Rozerem may help you fall asleep faster.

    When: For most patients, Rozerem acts quickly and therefore should be taken within 30 minutes of going to bed and only if you can get a full night's sleep. It is important that you take Rozerem exactly as your healthcare provider has prescribed. If your insomnia gets worse or is not better within 7 to 10 days, call your healthcare provider, as this may mean that there is another condition causing your sleep problems.

    How do I know it is working?

    If you are able to fall asleep faster than you normally would, Rozerem is likely working effectively. Your healthcare provider may ask you questions from time to time to assess your sleep pattern.

  • What are the possible side effects of this medication?

    The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.

    More common side effects may include: drowsiness, dizziness, fatigue, nausea, worsening of insomnia.

    Less common side effects may include:

    Serious allergic reactions with symptoms such as swelling of your tongue or throat; trouble breathing or swallowing; or nausea and vomiting.

    Abnormal thoughts and behavior with symptoms such as being more outgoing than usual, increased aggressiveness, confusion, agitation, hallucinations, anxiety, worsening of your depression, or suicidal thoughts or actions.

    Getting up out of bed while not being fully awake and engaging in activities that you do not know you are doing (such as driving a car ["sleep-driving"], making and eating food, talking on the phone, having sex, or sleep-walking).

    Changes in your hormones with symptoms such as decreased interest in sex, problems getting pregnant, irregular or no menstrual periods, or leakage of milk from the nipples when you are not breastfeeding.

  • Who should not take this medication?

    Do not take Rozerem if you are allergic to it or any of its ingredients.

    Do not take Rozerem in combination with fluvoxamine.

  • What should I tell my healthcare provider before I take the first dose of this medication?

    Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Rozerem. Also, talk to your healthcare provider about your complete medical history, especially if you have liver disease, lung disease, or breathing problems (such as sleep apnea [stopping breathing temporarily during sleep]); or if you have a history of depression, mental illness, or suicidal thoughts.

  • What is the usual dosage?

    The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.

    Adults: The recommended dose is 8 milligrams taken within 30 minutes of going to bed.

  • How should I take this medication?

    Take Rozerem exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Rozerem without first talking to your healthcare provider.

    Swallow Rozerem tablets whole. Do not break, crush, or chew them.

    Take Rozerem within 30 minutes before going to bed and limit your activities to those necessary to prepare for bed. Only take Rozerem if you are able to stay in bed for a full night's sleep before you must be active again.

    Do not take Rozerem with or right after a meal. Rozerem may help you fall asleep faster if you take it on an empty stomach.

  • What should I avoid while taking this medication?

    Do not drink alcohol while you are taking Rozerem.

    Do not drive or engage in other activities that require complete alertness after taking Rozerem until you feel fully awake.

  • What are the possible food and drug interactions associated with this medication?

    If Rozerem is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your healthcare provider before combining Rozerem with the following: alcohol, donepezil, doxepin, fluconazole, fluvoxamine, ketoconazole, or rifampin.

  • May I receive this medication if I am pregnant or breastfeeding?

    The effects of Rozerem during pregnancy and breastfeeding are unknown. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

  • What should I do if I miss a dose of this medication?

    Rozerem should be taken under special circumstances determined by your healthcare provider. If you miss your scheduled dose, contact your healthcare provider or pharmacist for advice.

  • How should I store this medication?

    Store at room temperature. Protect from moisture.

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