increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.voriconazoleMinor (2)voriconazole will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown. voriconazole will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.xylometazolineMonitor Closely (1)ramelteon increases and xylometazoline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.zafirlukastMinor (2)zafirlukast will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown. zafirlukast will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.ziconotideMonitor Closely (1)ramelteon and ziconotide both increase sedation. Use Caution/Monitor.zileutonMonitor Closely (1)zileuton will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.ziprasidoneMonitor Closely (1)ziprasidone and ramelteon both increase sedation. Use Caution/Monitor. 1-10% Dizziness Somnolence (similar to placebo) Fatigue Headache Dysgeusia Nausea Frequency Not Defined Depression Worsening of insomnia Hallucinations Mania Angioedema (rare ) Contraindications Hypersensitivity History of angioedema with previous therapy Concomitant fluvoxamine Cautions Angioedema and anaphylaxis reported; do not rechallenge if such reactions occur Reevaluate if insomnia persists after 7-10 days of treatment Abnormal thinking, behavioral changes, complex behaviors, including “sleep-driving” and hallucinations; immediately evaluate any new onset of behavioral changes Worsening of depression or suicidal thinking may occur May impair activities requiring complete mental alertness such as operating machinery or driving a motor vehicle, after ingesting the drug Endocrine effects include decreased testosterone and increased prolactin levels; effect on reproductive axis in developing humans unknown Use caution in patients with respiratory compromise, including sleep apnea or COPD; not recommended in patients with severe sleep apnea Use caution in patients with hepatic impairment; not recommended in severe hepatic impairment Review drug interactions database for significant drug interactions Pregnancy Available data from postmarketing reports with use in pregnant women have not identified drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes Animal data In animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than 36 times recommended human dose (RHD) of 8 mg/day based on body surface area (mg/m2) Lactation There are no data regarding presence of drug or metabolites in human milk, effects on breastfed infant, or on milk production The drug and/or its metabolites are present in rat milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk; because of mechanism of action of drug, there is a potential risk for somnolence in a breastfed infant; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed infant from drug or from underlying maternal condition Infants exposed to drug through breastmilk should be monitored for somnolence and feeding problems; a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 25 hours (approximately 5 elimination half-lives) after drug administration in order to minimize drug exposure to a breastfed infantPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Melatonin receptor agonist with high affinity for MT1 & MT2 receptors Absorption Absorption: 84% Bioavailability: 1.8% Distribution Protein bound: 82% Metabolism Extensive first-pass metabolism; mostly by hepatic CYP1A2 Excretion Urine: 84% Feces: 4% Oral Administration Take within 30 min of going to bed Do not take with or immediately after high fat meal BRAND FORM. UNIT PRICE PILL IMAGE Rozerem oral- 8 mg tabletramelteon oral- 8 mg tabletramelteon oral- 8 mg tabletramelteon oral- 8 mg tabletramelteon oral- 8 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationramelteon oral RAMELTEON - ORAL (ra-MEL-tee-on) COMMON BRAND NAME(S): Rozerem 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 as directed by your doctor, usually 30 minutes before bedtime. 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 often 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.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).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. NOTES: Do not share this medication with others.Lab and/or medical tests (such as hormone levels) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.Lifestyle changes that can help you get to sleep include reducing stress, not smoking, avoiding caffeine and alcoholic beverages for at least 4 to 6 hours before bedtime, listening to relaxing music, and doing relaxation exercises. Get up and go to bed at the same time each day. Don't take naps during the day, and make sure your bedroom is quiet and comfortable. 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. Information last revised May 2023. Copyright(c) 2023 First Databank, Inc. 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. FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information