ramelteon (Rx)

Brand and Other Names:Rozerem
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Dosing & Uses

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Dosage Forms & Strengths

tablet

  • 8mg

Insomnia

8 mg PO qHS

Safety and efficacy not established

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Interactions

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            Contraindicated (3)

            • calcium/magnesium/potassium/sodium oxybates

              ramelteon, calcium/magnesium/potassium/sodium oxybates. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration with alcohol or sedative hypnotics are contraindicated because of additive CNS depression.

            • fluvoxamine

              fluvoxamine will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Contraindicated.

            • sodium oxybate

              ramelteon, sodium oxybate. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration with alcohol or sedative hypnotics are contraindicated because of additive CNS depression.

            Serious - Use Alternative (15)

            • abametapir

              abametapir will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP1A2 substrates. If not feasible, avoid use of abametapir.

            • benzhydrocodone/acetaminophen

              benzhydrocodone/acetaminophen, ramelteon. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • fentanyl

              fentanyl, ramelteon. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

            • fentanyl intranasal

              fentanyl intranasal, ramelteon. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

            • fentanyl transdermal

              fentanyl transdermal, ramelteon. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

            • fentanyl transmucosal

              fentanyl transmucosal, ramelteon. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

            • givosiran

              givosiran will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP1A2 substrates with givosiran. If unavoidable, decrease the CYP1A2 substrate dosage in accordance with approved product labeling.

            • hydrocodone

              hydrocodone, ramelteon. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • lemborexant

              lemborexant, ramelteon. Either increases effects of the other by sedation. Avoid or Use Alternate Drug. Use of lemborexant with other drugs to treat insomnia is not recommended.

            • metoclopramide intranasal

              ramelteon, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

            • oxycodone

              ramelteon and oxycodone both increase sedation. Avoid or Use Alternate Drug. Additive CNS depression may lead to hypotension, profound sedation, respiratory depression, or coma

            • pefloxacin

              pefloxacin will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

            • selinexor

              selinexor, ramelteon. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

            • sufentanil SL

              sufentanil SL, ramelteon. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration may result in hypotension, profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • valerian

              valerian and ramelteon both increase sedation. Avoid or Use Alternate Drug.

            Monitor Closely (184)

            • alfentanil

              alfentanil and ramelteon both increase sedation. Use Caution/Monitor.

            • alprazolam

              alprazolam and ramelteon both increase sedation. Use Caution/Monitor.

            • amitriptyline

              amitriptyline and ramelteon both increase sedation. Use Caution/Monitor.

            • amobarbital

              amobarbital will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              amobarbital and ramelteon both increase sedation. Use Caution/Monitor.

            • amoxapine

              amoxapine and ramelteon both increase sedation. Use Caution/Monitor.

            • apomorphine

              apomorphine and ramelteon both increase sedation. Use Caution/Monitor.

            • aripiprazole

              aripiprazole and ramelteon both increase sedation. Use Caution/Monitor.

            • armodafinil

              armodafinil will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • azelastine

              azelastine and ramelteon both increase sedation. Use Caution/Monitor.

            • baclofen

              baclofen and ramelteon both increase sedation. Use Caution/Monitor.

            • belladonna and opium

              belladonna and opium and ramelteon both increase sedation. Use Caution/Monitor.

            • benperidol

              benperidol and ramelteon both increase sedation. Use Caution/Monitor.

            • benzphetamine

              ramelteon increases and benzphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • brexanolone

              brexanolone, ramelteon. Either increases toxicity of the other by sedation. Use Caution/Monitor.

            • brompheniramine

              brompheniramine and ramelteon both increase sedation. Use Caution/Monitor.

            • buprenorphine

              buprenorphine and ramelteon both increase sedation. Use Caution/Monitor.

            • buprenorphine buccal

              buprenorphine buccal and ramelteon both increase sedation. Use Caution/Monitor.

            • buprenorphine, long-acting injection

              ramelteon increases toxicity of buprenorphine, long-acting injection by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of buprenorphine and benzodiazepines or other CNS depressants increases risk of adverse reactions including overdose, respiratory depression, and death. Cessation of benzodiazepines or other CNS depressants is preferred in most cases. In some cases, monitoring at a higher level of care for tapering CNS depressants may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or decreasing to the lowest effective dose may be appropriate.

            • butabarbital

              butabarbital will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              butabarbital and ramelteon both increase sedation. Use Caution/Monitor.

            • butalbital

              butalbital will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              butalbital and ramelteon both increase sedation. Use Caution/Monitor.

            • butorphanol

              butorphanol and ramelteon both increase sedation. Use Caution/Monitor.

            • cannabidiol

              cannabidiol, ramelteon. affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Owing to the potential for both CYP1A2 induction and inhibition with the coadministration of CYP1A2 substrates and cannabidiol, consider reducing dosage adjustment of CYP1A2 substrates as clinically appropriate.

            • carbamazepine

              carbamazepine will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              carbamazepine will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • carbinoxamine

              carbinoxamine and ramelteon both increase sedation. Use Caution/Monitor.

            • carisoprodol

              carisoprodol and ramelteon both increase sedation. Use Caution/Monitor.

            • chloral hydrate

              chloral hydrate and ramelteon both increase sedation. Use Caution/Monitor.

            • chlordiazepoxide

              chlordiazepoxide and ramelteon both increase sedation. Use Caution/Monitor.

            • chlorpheniramine

              chlorpheniramine and ramelteon both increase sedation. Use Caution/Monitor.

            • chlorpromazine

              chlorpromazine and ramelteon both increase sedation. Use Caution/Monitor.

            • chlorzoxazone

              chlorzoxazone and ramelteon both increase sedation. Use Caution/Monitor.

            • cigarette smoking

              cigarette smoking will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • cimetidine

              cimetidine will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              cimetidine will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • cinnarizine

              cinnarizine and ramelteon both increase sedation. Use Caution/Monitor.

            • ciprofloxacin

              ciprofloxacin will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Ciprofloxacin may decrease the metabolism of ramelteon; if ciprofloxacin is coadministered with ramelteon, monitor the patient closely for toxicity.

            • clemastine

              clemastine and ramelteon both increase sedation. Use Caution/Monitor.

            • clomipramine

              clomipramine and ramelteon both increase sedation. Use Caution/Monitor.

            • clonazepam

              clonazepam and ramelteon both increase sedation. Use Caution/Monitor.

            • clorazepate

              clorazepate and ramelteon both increase sedation. Use Caution/Monitor.

            • clozapine

              clozapine and ramelteon both increase sedation. Use Caution/Monitor.

            • codeine

              codeine and ramelteon both increase sedation. Use Caution/Monitor.

            • cyclizine

              cyclizine and ramelteon both increase sedation. Use Caution/Monitor.

            • cyclobenzaprine

              cyclobenzaprine and ramelteon both increase sedation. Use Caution/Monitor.

            • cyproheptadine

              cyproheptadine and ramelteon both increase sedation. Use Caution/Monitor.

            • dantrolene

              dantrolene and ramelteon both increase sedation. Use Caution/Monitor.

            • deferasirox

              deferasirox increases levels of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • desipramine

              desipramine and ramelteon both increase sedation. Use Caution/Monitor.

            • deutetrabenazine

              ramelteon and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • dexchlorpheniramine

              dexchlorpheniramine and ramelteon both increase sedation. Use Caution/Monitor.

            • dexfenfluramine

              ramelteon increases and dexfenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dexmedetomidine

              dexmedetomidine and ramelteon both increase sedation. Use Caution/Monitor.

            • dextromoramide

              dextromoramide and ramelteon both increase sedation. Use Caution/Monitor.

            • diamorphine

              diamorphine and ramelteon both increase sedation. Use Caution/Monitor.

            • diazepam

              diazepam and ramelteon both increase sedation. Use Caution/Monitor.

            • diazepam intranasal

              diazepam intranasal, ramelteon. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may potentiate the CNS-depressant effects of each drug.

            • difenoxin hcl

              difenoxin hcl and ramelteon both increase sedation. Use Caution/Monitor.

            • dimenhydrinate

              dimenhydrinate and ramelteon both increase sedation. Use Caution/Monitor.

            • diphenhydramine

              diphenhydramine and ramelteon both increase sedation. Use Caution/Monitor.

            • diphenoxylate hcl

              diphenoxylate hcl and ramelteon both increase sedation. Use Caution/Monitor.

            • dipipanone

              dipipanone and ramelteon both increase sedation. Use Caution/Monitor.

            • donepezil

              donepezil will increase the level or effect of ramelteon by unspecified interaction mechanism. Use Caution/Monitor. AUC and Cmax increased by 100% and 87% respectively.

            • dopexamine

              ramelteon increases and dopexamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • doxepin

              doxepin and ramelteon both increase sedation. Use Caution/Monitor.

              doxepin will increase the level or effect of ramelteon by unspecified interaction mechanism. Use Caution/Monitor. AUC and Cmax increased by 66% and 69% respectively.

            • doxylamine

              doxylamine and ramelteon both increase sedation. Use Caution/Monitor.

            • droperidol

              droperidol and ramelteon both increase sedation. Use Caution/Monitor.

            • efavirenz

              efavirenz will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

            • erythromycin base

              erythromycin base will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              erythromycin base will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              erythromycin ethylsuccinate will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              erythromycin lactobionate will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • erythromycin stearate

              erythromycin stearate will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              erythromycin stearate will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • esketamine intranasal

              esketamine intranasal, ramelteon. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

            • estazolam

              estazolam and ramelteon both increase sedation. Use Caution/Monitor.

            • ethanol

              ethanol and ramelteon both increase sedation. Use Caution/Monitor.

            • ethinylestradiol

              ethinylestradiol will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • etomidate

              etomidate and ramelteon both increase sedation. Use Caution/Monitor.

            • fenfluramine

              ramelteon increases and fenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • fexinidazole

              fexinidazole will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • flibanserin

              ramelteon and flibanserin both increase sedation. Modify Therapy/Monitor Closely. Risk for sedation increased if flibanserin is coadministration with other CNS depressants.

            • fluoxetine

              fluoxetine will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

            • fluphenazine

              fluphenazine and ramelteon both increase sedation. Use Caution/Monitor.

            • flurazepam

              flurazepam and ramelteon both increase sedation. Use Caution/Monitor.

            • fluvoxamine

              fluvoxamine will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

            • gabapentin

              gabapentin, ramelteon. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

            • gabapentin enacarbil

              gabapentin enacarbil, ramelteon. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

            • haloperidol

              haloperidol and ramelteon both increase sedation. Use Caution/Monitor.

            • hydromorphone

              hydromorphone and ramelteon both increase sedation. Use Caution/Monitor.

            • hydroxyzine

              hydroxyzine and ramelteon both increase sedation. Use Caution/Monitor.

            • iloperidone

              iloperidone and ramelteon both increase sedation. Use Caution/Monitor.

            • imatinib

              imatinib will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

            • imipramine

              imipramine and ramelteon both increase sedation. Use Caution/Monitor.

            • isoniazid

              isoniazid will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • itraconazole

              itraconazole will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ketamine

              ketamine and ramelteon both increase sedation. Use Caution/Monitor.

            • ketoconazole

              ketoconazole will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ketotifen, ophthalmic

              ketotifen, ophthalmic and ramelteon both increase sedation. Use Caution/Monitor.

            • lasmiditan

              lasmiditan, ramelteon. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.

            • letermovir

              letermovir increases levels of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • levorphanol

              levorphanol and ramelteon both increase sedation. Use Caution/Monitor.

            • lofepramine

              lofepramine and ramelteon both increase sedation. Use Caution/Monitor.

            • lofexidine

              lofexidine and ramelteon both increase sedation. Use Caution/Monitor.

            • loprazolam

              loprazolam and ramelteon both increase sedation. Use Caution/Monitor.

            • lorazepam

              lorazepam and ramelteon both increase sedation. Use Caution/Monitor.

            • lormetazepam

              lormetazepam and ramelteon both increase sedation. Use Caution/Monitor.

            • loxapine

              loxapine and ramelteon both increase sedation. Use Caution/Monitor.

            • loxapine inhaled

              loxapine inhaled and ramelteon both increase sedation. Use Caution/Monitor.

            • lurasidone

              lurasidone, ramelteon. Either increases toxicity of the other by sedation. Use Caution/Monitor. Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.

            • maprotiline

              maprotiline and ramelteon both increase sedation. Use Caution/Monitor.

            • marijuana

              marijuana and ramelteon both increase sedation. Use Caution/Monitor.

            • melatonin

              melatonin and ramelteon both increase sedation. Use Caution/Monitor.

            • meperidine

              meperidine and ramelteon both increase sedation. Use Caution/Monitor.

            • meprobamate

              meprobamate and ramelteon both increase sedation. Use Caution/Monitor.

            • metaxalone

              metaxalone and ramelteon both increase sedation. Use Caution/Monitor.

            • methadone

              methadone and ramelteon both increase sedation. Use Caution/Monitor.

            • methocarbamol

              methocarbamol and ramelteon both increase sedation. Use Caution/Monitor.

            • methylenedioxymethamphetamine

              ramelteon increases and methylenedioxymethamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • mexiletine

              mexiletine will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • midazolam

              midazolam and ramelteon both increase sedation. Use Caution/Monitor.

            • midazolam intranasal

              midazolam intranasal, ramelteon. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

            • mirtazapine

              mirtazapine and ramelteon both increase sedation. Use Caution/Monitor.

            • modafinil

              modafinil will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • morphine

              morphine and ramelteon both increase sedation. Use Caution/Monitor.

            • motherwort

              motherwort and ramelteon both increase sedation. Use Caution/Monitor.

            • moxonidine

              moxonidine and ramelteon both increase sedation. Use Caution/Monitor.

            • nabilone

              nabilone and ramelteon both increase sedation. Use Caution/Monitor.

            • nalbuphine

              nalbuphine and ramelteon both increase sedation. Use Caution/Monitor.

            • nefazodone

              nefazodone will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nortriptyline

              nortriptyline and ramelteon both increase sedation. Use Caution/Monitor.

            • olanzapine

              olanzapine and ramelteon both increase sedation. Use Caution/Monitor.

            • oliceridine

              oliceridine, ramelteon. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • opium tincture

              opium tincture and ramelteon both increase sedation. Use Caution/Monitor.

            • orphenadrine

              orphenadrine and ramelteon both increase sedation. Use Caution/Monitor.

            • oxazepam

              oxazepam and ramelteon both increase sedation. Use Caution/Monitor.

            • oxycodone

              oxycodone and ramelteon both increase sedation. Use Caution/Monitor.

            • oxymorphone

              oxymorphone and ramelteon both increase sedation. Use Caution/Monitor.

            • paliperidone

              paliperidone and ramelteon both increase sedation. Use Caution/Monitor.

            • papaveretum

              papaveretum and ramelteon both increase sedation. Use Caution/Monitor.

            • papaverine

              papaverine and ramelteon both increase sedation. Use Caution/Monitor.

            • pentazocine

              pentazocine and ramelteon both increase sedation. Use Caution/Monitor.

            • pentobarbital

              pentobarbital will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              pentobarbital and ramelteon both increase sedation. Use Caution/Monitor.

            • perphenazine

              perphenazine and ramelteon both increase sedation. Use Caution/Monitor.

            • phenobarbital

              phenobarbital will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              phenobarbital and ramelteon both increase sedation. Use Caution/Monitor.

            • phenylephrine PO

              ramelteon increases and phenylephrine PO decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

            • pholcodine

              pholcodine and ramelteon both increase sedation. Use Caution/Monitor.

            • pimozide

              pimozide and ramelteon both increase sedation. Use Caution/Monitor.

            • pipemidic acid

              pipemidic acid will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • pregabalin

              pregabalin, ramelteon. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

            • primidone

              primidone will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              primidone and ramelteon both increase sedation. Use Caution/Monitor.

            • prochlorperazine

              prochlorperazine and ramelteon both increase sedation. Use Caution/Monitor.

            • promethazine

              promethazine and ramelteon both increase sedation. Use Caution/Monitor.

            • propofol

              propofol and ramelteon both increase sedation. Use Caution/Monitor.

            • propylhexedrine

              ramelteon increases and propylhexedrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • protriptyline

              protriptyline and ramelteon both increase sedation. Use Caution/Monitor.

            • quazepam

              quazepam and ramelteon both increase sedation. Use Caution/Monitor.

            • quetiapine

              quetiapine and ramelteon both increase sedation. Use Caution/Monitor.

            • remimazolam

              remimazolam, ramelteon. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely. Coadministration may result in profound sedation, respiratory depression, coma, and/or death. Continuously monitor vital signs during sedation and recovery period if coadministered. Carefully titrate remimazolam dose if administered with opioid analgesics and/or sedative/hypnotics.

            • ribociclib

              ribociclib will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rifabutin

              rifabutin will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rifampin

              rifampin will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              rifampin will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • risperidone

              risperidone and ramelteon both increase sedation. Use Caution/Monitor.

            • rucaparib

              rucaparib will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP1A2 substrates, if clinically indicated.

            • scullcap

              ramelteon and scullcap both increase sedation. Use Caution/Monitor.

            • secobarbital

              secobarbital will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              secobarbital and ramelteon both increase sedation. Use Caution/Monitor.

            • shepherd's purse

              ramelteon and shepherd's purse both increase sedation. Use Caution/Monitor.

            • smoking

              smoking will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • St John's Wort

              St John's Wort will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • stiripentol

              stiripentol, ramelteon. affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP1A2 inhibitor and inducer. Monitor CYP1A2 substrates coadministered with stiripentol for increased or decreased effects. CYP1A2 substrates may require dosage adjustment.

            • sufentanil

              sufentanil and ramelteon both increase sedation. Use Caution/Monitor.

            • tapentadol

              tapentadol and ramelteon both increase sedation. Use Caution/Monitor.

            • temazepam

              temazepam and ramelteon both increase sedation. Use Caution/Monitor.

            • teriflunomide

              teriflunomide decreases levels of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • thioridazine

              thioridazine and ramelteon both increase sedation. Use Caution/Monitor.

            • thiothixene

              thiothixene and ramelteon both increase sedation. Use Caution/Monitor.

            • tobacco use

              tobacco use will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • topiramate

              ramelteon and topiramate both increase sedation. Modify Therapy/Monitor Closely.

            • tramadol

              tramadol and ramelteon both increase sedation. Use Caution/Monitor.

            • trazodone

              trazodone and ramelteon both increase sedation. Use Caution/Monitor.

            • triazolam

              triazolam and ramelteon both increase sedation. Use Caution/Monitor.

            • triclofos

              triclofos and ramelteon both increase sedation. Use Caution/Monitor.

            • trifluoperazine

              trifluoperazine and ramelteon both increase sedation. Use Caution/Monitor.

            • trimipramine

              trimipramine and ramelteon both increase sedation. Use Caution/Monitor.

            • triprolidine

              triprolidine and ramelteon both increase sedation. Use Caution/Monitor.

            • xylometazoline

              ramelteon increases and xylometazoline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • ziconotide

              ramelteon and ziconotide both increase sedation. Use Caution/Monitor.

            • zileuton

              zileuton will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • ziprasidone

              ziprasidone and ramelteon both increase sedation. Use Caution/Monitor.

            Minor (63)

            • amiodarone

              amiodarone will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • amobarbital

              amobarbital will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              amobarbital will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • aprepitant

              aprepitant will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • armodafinil

              armodafinil will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • artemether/lumefantrine

              artemether/lumefantrine will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • atazanavir

              atazanavir will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • bosentan

              bosentan will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              bosentan will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • butabarbital

              butabarbital will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              butabarbital will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • butalbital

              butalbital will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              butalbital will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • carbamazepine

              carbamazepine will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • cimetidine

              cimetidine will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • clarithromycin

              clarithromycin will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • conivaptan

              conivaptan will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • darifenacin

              darifenacin will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • darunavir

              darunavir will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • dasatinib

              dasatinib will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • dexamethasone

              dexamethasone will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • DHEA, herbal

              DHEA, herbal will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • disulfiram

              disulfiram will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • dronedarone

              dronedarone will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • efavirenz

              efavirenz will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • eslicarbazepine acetate

              eslicarbazepine acetate will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • ethinylestradiol

              ethinylestradiol will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • etravirine

              etravirine will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              etravirine will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • eucalyptus

              eucalyptus and ramelteon both increase sedation. Minor/Significance Unknown.

            • fluconazole

              fluconazole will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              fluconazole will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • fosamprenavir

              fosamprenavir will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • grapefruit

              grapefruit will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • griseofulvin

              griseofulvin will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • hydrocortisone

              hydrocortisone will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • indinavir

              indinavir will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • isoniazid

              isoniazid will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • ketoconazole

              ketoconazole will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • lapatinib

              lapatinib will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • leflunomide

              leflunomide will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • lumefantrine

              lumefantrine will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • marijuana

              marijuana will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • metronidazole

              metronidazole will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              metronidazole will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • miconazole vaginal

              miconazole vaginal will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              miconazole vaginal will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • modafinil

              modafinil will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • nelfinavir

              nelfinavir will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • nevirapine

              nevirapine will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • nifedipine

              nifedipine will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • nilotinib

              nilotinib will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • oxcarbazepine

              oxcarbazepine will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • pentobarbital

              pentobarbital will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              pentobarbital will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • phenobarbital

              phenobarbital will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              phenobarbital will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • phenytoin

              phenytoin will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • posaconazole

              posaconazole will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • primidone

              primidone will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              primidone will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • quinupristin/dalfopristin

              quinupristin/dalfopristin will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • rifampin

              rifampin will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • rifapentine

              rifapentine will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              rifapentine will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • ritonavir

              ritonavir will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • rufinamide

              rufinamide will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • sage

              ramelteon and sage both increase sedation. Minor/Significance Unknown.

            • secobarbital

              secobarbital will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              secobarbital will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • sulfamethoxazole

              sulfamethoxazole will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • topiramate

              topiramate will decrease the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • verapamil

              verapamil will increase the level or effect of ramelteon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • voriconazole

              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.

            • zafirlukast

              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.

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            Adverse Effects

            1-10%

            Dizziness

            Somnolence (similar to placebo)

            Fatigue

            Headache

            Dysgeusia

            Nausea

            Frequency Not Defined

            Depression

            Worsening of insomnia

            Hallucinations

            Mania

            Angioedema (rare )

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            Warnings

            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

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            Pregnancy & Lactation

            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 infant

            Pregnancy 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.

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            Pharmacology

            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%

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            Administration

            Oral Administration

            Take within 30 min of going to bed

            Do not take with or immediately after high fat meal

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            ramelteon oral
            -
            8 mg tablet
            ramelteon oral
            -
            8 mg tablet
            ramelteon oral
            -
            8 mg tablet
            Rozerem oral
            -
            8 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            ramelteon 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, 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 (e.g., 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 persist or worsen, 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 (e.g., 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.

            NOTES: Do not share this medication with others. Laboratory tests (e.g., hormone levels) may be performed if you have certain side effects. 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 September 2021. Copyright(c) 2021 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.

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            Formulary

            FormularyPatient Discounts

            Adding 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.

            Adding 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 changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.