Dosing & Uses
Dosage Forms & Strengths
tablet
- 8mg
Insomnia
8 mg PO qHS
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (16)
- 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.
- leniolisib
leniolisib will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index
- 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.
- olopatadine intranasal
ramelteon and olopatadine intranasal both increase sedation. Avoid or Use Alternate Drug. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.
- 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 (207)
- acrivastine
acrivastine and ramelteon both increase sedation. Use Caution/Monitor.
- 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.
- asenapine
asenapine and ramelteon both increase sedation. Use Caution/Monitor.
- asenapine transdermal
asenapine transdermal and ramelteon both increase sedation. Use Caution/Monitor.
- avapritinib
avapritinib and ramelteon both increase sedation. 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.
- benzhydrocodone/acetaminophen
benzhydrocodone/acetaminophen 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.
- brexpiprazole
brexpiprazole and ramelteon both increase sedation. Use Caution/Monitor.
- brimonidine
brimonidine and ramelteon both increase sedation. Use Caution/Monitor.
- brivaracetam
brivaracetam and ramelteon both increase 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 subdermal implant
buprenorphine subdermal implant and ramelteon both increase sedation. Use Caution/Monitor.
- buprenorphine transdermal
buprenorphine transdermal 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.
buprenorphine, long-acting injection and ramelteon both increase sedation. Use Caution/Monitor. - 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.
- daridorexant
ramelteon and daridorexant both increase sedation. Modify Therapy/Monitor Closely. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.
- 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.
- difelikefalin
difelikefalin and ramelteon both increase sedation. Use Caution/Monitor.
- 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.
- elranatamab
elranatamab will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- epcoritamab
epcoritamab, ramelteon. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Epcoritamab causes release of cytokines that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. For certain CYP substrates, minimal changes in their concentration may lead to serious adverse reactions. If needed, modify therapy as recommended in the substrate's prescribing information. .
- 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.
- ganaxolone
ramelteon and ganaxolone both increase sedation. Use Caution/Monitor.
- glofitamab
glofitamab, ramelteon. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Glofitamab causes release of cytokines that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. For certain CYP substrates, minimal changes in their concentration may lead to serious adverse reactions. If needed, modify therapy as recommended in the substrate's prescribing information. .
- 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.
- levoketoconazole
levoketoconazole will increase the level or effect 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.
- lonapegsomatropin
lonapegsomatropin will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- 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.
- ritlecitinib
ritlecitinib will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Ritlecitinib inhibits CYP1A2 substrates; coadministration increases AUC and peak plasma concentration sensitive substrates, which may increase risk of adverse reactions. Additional monitoring and dosage adjustment may be needed in accordance with product labeling of CYP1A2 substrates.
- 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.
- somapacitan
somapacitan will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- somatrogon
somatrogon will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- somatropin
somatropin will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- 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.
- talquetamab
talquetamab will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- 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 (64)
- 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.
- fosaprepitant
fosaprepitant 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.
- levoketoconazole
levoketoconazole 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. - 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.
Adverse Effects
1-10%
Dizziness
Somnolence (similar to placebo)
Fatigue
Headache
Dysgeusia
Nausea
Frequency Not Defined
Depression
Worsening of insomnia
Hallucinations
Mania
Angioedema (rare )
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
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.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%
Administration
Oral Administration
Take within 30 min of going to bed
Do not take with or immediately after high fat meal
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Rozerem oral - | 8 mg tablet |  | |
| ramelteon oral - | 8 mg tablet |  | |
| ramelteon oral - | 8 mg tablet |  | |
| ramelteon oral - | 8 mg tablet |  | |
| ramelteon oral - | 8 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 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.
Formulary
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