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Ramelteon

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What is Ramelteon?

Ramelteon (Rozerem), a melatonin receptor agonist, imitates the effects of melatonin. When it becomes dark, your body produces melatonin to aid in a regular sleep cycle. The melatonin-like drug ramelteon (Rozerem) accelerates the onset of sleepiness.

Why is Ramelteon recommended?

Ramelteon is prescribed to people who have trouble falling asleep due to sleep-onset insomnia. Ramelteon belongs to a group of drugs known as melatonin receptor agonists. It functions similarly to the brains naturally occurring melatonin, which is essential for sleep.

Detailed Product Description

How is this medication to be taken?

Ramelteon is available as an oral tablet. The recommended dosage is one dose per day, no earlier than 30 minutes prior to bedtime. Avoid taking Ramelteon right before or right after eating. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Ramelteon should be taken as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablets instead, swallow them whole.

A short time after taking ramelteon, you can feel tired. You should make any required bedtime preparations and then go to bed after taking ramelteon. Dont schedule any additional activities for this period. If you wont be able to sleep for seven to eight hours after taking ramelteon, do not take it.

Safety

Ramelteon doesnt appear to have any significant safety problems. After participating in the study for a year, 3.1% of the patients experienced one or more significant adverse events, but fewer than 10% of those occurrences were related to the drug ramelteon.

Patients who are taking fluvoxamine (Luvox), which can decrease the metabolism of ramelteon, or who have severe hepatic impairment shouldnt use ramelteon. The use of ramelteon raises blood levels of either fluconazole (Diflucan) or ketoconazole (Nizoral), which may enhance the risk of adverse effects or therapeutic effect. Taking ramelteon along with alcohol doesnt significantly increase its effects. Children and teenagers shouldnt use it because it hasnt been tested on them. Ramelteon is not advised for breastfeeding moms.

Tolerability

In general, ramelteon is well tolerated. Ramelteon had a 5% dropout rate during clinical trials compared to a 2% rate for placebo. Ramelteon doesnt leave behind any lingering "hangover" symptoms. Ramelteon did not result in rebound insomnia in studies lasting 35 days, and there was no sign of withdrawal after stopping the drug.

Important Patient Information

RAMELTEON - ORAL (ra-MEL-tee-on) COMMON BRAND NAME(S): Rozerem

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

USES: This medication is used to treat sleeplessness (insomnia). It helps you fall asleep faster so you can get a full night's rest. Sleep is important for your ability to function, think clearly, and remain alert. Lack of sleep can cause problems such as depression, heart disease and accidents. Getting enough sleep allows your mind and body to repair itself and increases your energy throughout the day. Ramelteon works like a natural substance called melatonin that is produced by your body. It helps regulate your sleep-wake cycle (circadian rhythm).

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking ramelteon and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food, 30 minutes before bedtime, or as directed by your doctor. Do not take ramelteon with or immediately after a high-fat meal because fat can affect how well this drug works. The manufacturer directs not to break the tablet before taking it. However, many similar drugs (immediate-release tablets) can be broken. Follow your doctor's directions on how to take this medication. Do not take a dose of this medication unless you have time for a full night's sleep that lasts at least 7 to 8 hours. Your dosage is based on your medical condition and response to therapy. Do not increase your dose or take it more frequently than prescribed. Inform your doctor if you have any changes in mood (such as feelings of depression), if you continue to have trouble falling asleep, or if your insomnia worsens.

SIDE EFFECTS: Dizziness, tiredness, or daytime drowsiness may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Some people who take sleep medications have reported getting out of bed and sleep-walking, driving, eating, talking on the phone, or doing other activities while not fully awake. Often, they have no memory of these activities. This problem can be dangerous to you or others. If you have or think you have this problem, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, strange thoughts, thoughts of suicide), decreased sexual desire, missed menstrual periods, nipple discharge, difficulty becoming pregnant. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ramelteon, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (bronchitis, emphysema, sleep apnea), liver disease. This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Alcohol may increase the risk of this drug's side effects and can worsen sleeping problems. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant (such as unusual sleepiness or difficulty feeding), ask your doctor if you should pump and discard your breast milk during treatment and for 25 hours after a dose of this medication to lessen the risk of these effects in your baby. Get medical help right away if you notice any unusual symptoms in your baby. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of ramelteon from your body, which may affect how ramelteon works. Examples include azole antifungals (such as fluconazole, ketoconazole), fluvoxamine, rifamycins (such as rifampin), viloxazine, among others. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

MISSED DOSE: Not applicable.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Prescribing Information

This product information is intended for United States residents only. Before prescribing, please refer to the patient information. You can view the document and also download it on your computer. You may also consider printing out a copy for yourself.

View US Prescribing Information - PDF Version

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