Medicine guide

Ramelteon

8 mg · Tablet, Film Coated

Prescription only
Melatonin Receptor Agonist

Active substance: Ramelteon
Made by: Asclemed USA, Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-01-17

What it is

Melatonin Receptor Agonist

Used for

Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.

The label’s usual adult dose

Adult dose: 8 mg taken within 30 minutes of going to bed.

The total ramelteon tablets dose should not exceed 8 mg per day.

Full directions ↓

Do not take it if

Patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

30other products contain Ramelteon — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.
The clinical trials performed in support of efficacy were up to six months in duration.
The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14) ] .
Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.
( 1 )

From the official label · 2025-01-17 · DailyMed

How it works

From this product’s own US prescribing label.

Ramelteon is a melatonin receptor agonist with both high affinity for melatonin MT 1 and MT 2 receptors and relative selectivity over the MT 3 receptor.
The activity of ramelteon at the MT 1 and MT 2 receptors is believed to contribute to its sleep- promoting properties, as these receptors, acted upon by endogenous melatonin, are thought to be involved in the maintenance of the circadian rhythm underlying the normal sleep-wake cycle.

Peak level after0.75 h

Half-life2.6 h

Mostly cleared after≈ 13 hfive half-lives — our arithmetic

The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

How the body breaks it down

CYP1A2 is the major isozyme involved in the hepatic metabolism of ramelteon; the CYP2C subfamily and CYP3A4 isozymes are also involved to a minor degree.

How it leaves the body

Following oral administration of radiolabeled ramelteon, 84% of total radioactivity was excreted in urine and approximately 4% in feces, resulting in a mean recovery of 88%.

With food

Effect of Food When administered with a high-fat meal, the AUC 0-inf for a single 16 mg dose of ramelteon was 31% higher and the C max was 22% lower than when given in a fasted state.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-01-17

Do not take it if

Patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug.
Patients should not take ramelteon tablets in conjunction with fluvoxamine [see Drug Interactions (7) ] .
History of angioedema while taking ramelteon tablets.
( 4 ) Fluvoxamine (strong CYP1A2 inhibitor):
Increases AUC for ramelteon and should not be used in combination.
( 7.1 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Adult dose: 8 mg taken within 30 minutes of going to bed.
( 2.1 ) Should not be taken with or immediately after a high-fat meal.
( 2.1 ) Total daily dose should not exceed 8 mg.
( 2.1 )
Dosage in
Adults The recommended dose of ramelteon tablets are 8 mg taken within 30 minutes of going to bed.
It is recommended that ramelteon tablets not be taken with or immediately after a high-fat meal.
The total ramelteon tablets dose should not exceed 8 mg per day.
2.2 Dosing in Patients with Hepatic Impairment Ramelteon tablets are not recommended in patients with severe hepatic impairment.
Ramelteon tablets should be used with caution in patients with moderate hepatic impairment [see Warnings and Precautions (5.6) , Clinical Pharmacology (12.4) ] .
2.3 Administration with Other Medications Ramelteon tablets should not be used in combination with fluvoxamine.
Ramelteon tablets should be used with caution in patients taking other CYP1A2 inhibiting drugs [see Drug Interactions (7) , Clinical Pharmacology (12.5) ].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Severe anaphylactic/anaphylactoid reactions:
Angioedema and anaphylaxis have been reported.
Do not rechallenge if such reactions occur.
( 5.1 ) Need to evaluate for comorbid diagnoses:
Reevaluate if insomnia persists after 7 to 10 days of treatment.
( 5.2 ) Abnormal thinking, behavioral changes, complex behaviors:
May include “sleep-driving” and hallucinations.
Immediately evaluate any new onset behavioral changes.
( 5.3 ) Depression: Worsening of depression or suicidal thinking may occur.
( 5.3 ) CNS effects:
Potential impairment of activities requiring complete mental alertness such as operating machinery or driving a motor vehicle, after ingesting the drug.
( 5.4 ) Reproductive effects:
Include decreased testosterone and increased prolactin levels.
Effect on reproductive axis in developing humans is unknown.
( 5.5 ) Patients with severe sleep apnea:
Ramelteon is not recommended for use in this population.
( 5.6 )
5.1 Severe Anaphylactic and Anaphylactoid Reactions Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of ramelteon.
Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis.
Some patients have required medical therapy in the emergency department.
If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal.
Patients who develop angioedema after treatment with ramelteon should not be rechallenged with the drug.
5.2 Need to Evaluate for Comorbid Diagnoses Since sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient.
The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated .
Worsening of insomnia, or the emergence of new cognitive or behavioral abnormalities, may be the result of an unrecognized underlying psychiatric or physical disorder and requires further evaluation of the patient.
Exacerbation of insomnia and emergence of cognitive and behavioral abnormalities were seen with ramelteon during the clinical development program .
5.3 Abnormal Thinking and Behavioral Changes A variety of cognitive and behavior changes have been reported to occur in association with the use of hypnotics.
In primarily depressed patients, worsening of depression (including suicidal ideation and completed suicides) has been reported in association with the use of hypnotics.
Hallucinations, as well as behavioral changes such as bizarre behavior, agitation and mania have been reported with ramelteon use.
Amnesia, anxiety and other neuro-psychiatric symptoms may also occur unpredictably.
Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a hypnotic) and other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex), with amnesia for the event, have been reported in association with hypnotic use.
The use of alcohol and other CNS depressants may increase the risk of such behaviors.
These events can occur in hypnotic-naive as well as in hypnotic-experienced persons.
Complex behaviors have been reported with the use of ramelteon.
Discontinuation of ramelteon should be strongly considered for patients who report any complex sleep behavior.
CNS Effects Patients should
avoid engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking ramelteon.
After taking ramelteon, patients should confine their activities to those necessary to prepare for bed.
Patients should be advised not to consume alcohol in combination with ramelteon as alcohol and ramelteon may have additive effects when used in conjunction.
5.5 Reproductive Effects Ramelteon has been associated with an effect on reproductive hormones in
adults, e.g., decreased testosterone levels and increased prolactin levels.
It is not known what effect chronic or even chronic intermittent use of ramelteon may have on the reproductive axis in developing humans [see Clinical Trials (14.3 )].
5.6 Use in Patients with Concomitant Illness Ramelteon has not been studied in subjects with severe sleep apnea and is not recommended for use in this population [see Use in Specific Populations (8.7) ] .
Ramelteon should not be used by patients with severe hepatic impairment [see Clinical Pharmacology (12.4) ] .
5.7 Laboratory Tests Monitoring No standard monitoring is required.
For patients presenting with unexplained amenorrhea, galactorrhea, decreased libido, or problems with fertility, assessment of prolactin levels and testosterone levels should be considered as appropriate.
Interference with Laboratory Tests Ramelteon is not known to interfere with commonly used clinical laboratory tests.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary Available data from postmarketing reports with ramelteon use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
In animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than 36 times the recommended human dose (RHD) of 8 mg/day based on body surface area (mg/m 2 ) (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Oral administration of ramelteon (10, 40, 150 or 600 mg/kg/day) to pregnant rats during the period of organogenesis was associated with increased incidences of fetal structural abnormalities (malformations and variations) at doses greater than 40 mg/kg/day.
The no-effect dose is approximately 50 times the RHD based on mg/m 2 .
Treatment of pregnant rabbits during the period of organogenesis produced no evidence of embryo-fetal toxicity at oral doses of up to 300 mg/kg/day (or up to 720 times the RHD based on mg/m 2 ).
When rats were orally administered ramelteon (30, 100, or 300 mg/kg/day) throughout gestation and lactation, growth retardation, developmental delay, and behavioral changes were observed in the offspring at doses greater than 30 mg/kg/day.
The no-effect dose is 36 times the RHD based on mg/m 2 .
Increased incidences of malformation and death among offspring were seen at the highest dose.
IN SPECIFIC POPULATIONS Pediatric use: Safety and effectiveness not established.
( 8.4 ) Geriatric use:
No overall differences in safety and efficacy between elderly and younger adult subjects.
( 8.5 ) Hepatic impairment:
Is not recommended in patients with severe impairment; use with caution in moderate impairment.
( 8.8 )
8.1 Pregnancy Risk Summary Available data from postmarketing reports with ramelteon use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
In animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than 36 times the recommended human dose (RHD) of 8 mg/day based on body surface area (mg/m 2 ) (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Oral administration of ramelteon (10, 40, 150 or 600 mg/kg/day) to pregnant rats during the period of organogenesis was associated with increased incidences of fetal structural abnormalities (malformations and variations) at doses greater than 40 mg/kg/day.
The no-effect dose is approximately 50 times the RHD based on mg/m 2 .
Treatment of pregnant rabbits during the period of organogenesis produced no evidence of embryo-fetal toxicity at oral doses of up to 300 mg/kg/day (or up to 720 times the RHD based on mg/m 2 ).
When rats were orally administered ramelteon (30, 100, or 300 mg/kg/day) throughout gestation and lactation, growth retardation, developmental delay, and behavioral changes were observed in the offspring at doses greater than 30 mg/kg/day.
The no-effect dose is 36 times the RHD based on mg/m 2 .
Increased incidences of malformation and death among offspring were seen at the highest dose.
8.2 Lactation Risk Summary There are no data regarding the presence of ramelteon or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
Ramelteon 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 the mechanism of action of ramelteon, there is a potential risk for somnolence in a breastfed infant (see Clinical Considerations) .
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ramelteon and any potential adverse effects on the breastfed infant from ramelteon or from the underlying maternal condition.
Clinical Considerations Infants exposed to ramelteon 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 ramelteon administration in order to minimize drug exposure to a breastfed infant.
8.4 Pediatric Use Safety and effectiveness of ramelteon in pediatric patients have not been established.
Further study is needed prior to determining that this product may be used safely in prepubescent and pubescent patients.
8.5 Geriatric Use A total of 654 subjects in double-blind, placebo-controlled, efficacy trials who received ramelteon were at least 65 years of age; of these, 199 were 75 years of age or older.
No overall differences in safety or efficacy were observed between elderly and younger adult subjects.
A double-blind, randomized, placebo-controlled study in elderly subjects with insomnia (n=33) evaluated the effect of a single dose of ramelteon on balance, mobility, and memory functions after middle of the night awakening.
There is no information on the effect of multiple dosing.
Night time dosing of ramelteon 8 mg did not impair middle of the night balance, mobility, or memory functions relative to placebo.
The effects on night balance in the elderly cannot be definitively known from this study.
8.6 Chronic Obstructive Pulmonary Disease The respiratory depressant effect of ramelteon was evaluated in a crossover design study of subjects (n=26) with mild to moderate COPD after administering a single 16 mg dose or placebo, and in a separate study (n=25), the effects of ramelteon on respiratory parameters were evaluated after administering an 8 mg dose or placebo in a crossover design to patients with moderate to severe COPD, defined as patients who had forced expiratory volume at one second (FEV1)/forced vital capacity ratio of <70%, and a FEV1 <80% of predicted with <12% reversibility to albuterol.
Treatment with a single dose of ramelteon has no demonstrable respiratory depressant effects in subjects with mild to severe COPD, as measured by arterial O2 saturation (SaO2).
There is no available information on the respiratory effects of multiple doses of ramelteon in patients with COPD.
The respiratory depressant effects in patients with COPD cannot be definitively known from this study.
8.7 Sleep Apnea The effects of ramelteon were evaluated after administering a 16 mg dose or placebo in a crossover design to subjects (n=26) with mild to moderate obstructive sleep apnea.
Treatment with ramelteon 16 mg for one night showed no difference compared with placebo on the Apnea/Hypopnea Index (the primary outcome variable), apnea index, hypopnea index, central apnea index, mixed apnea index, and obstructive apnea index.
Treatment with a single dose of ramelteon does not exacerbate mild to moderate obstructive sleep apnea.
There is no available information on the respiratory effects of multiple doses of ramelteon in patients with sleep apnea.
The effects on exacerbation in patients with mild to moderate sleep apnea cannot be definitively known from this study.
Ramelteon has not been studied in subjects with severe obstructive sleep apnea; use of ramelteon is not recommended in such patients.
8.8 Hepatic Impairment Exposure to ramelteon was increased by four-fold in subjects with mild hepatic impairment and by more than ten-fold in subjects with moderate hepatic impairment.
Ramelteon should be used with caution in patients with moderate hepatic impairment [see Clinical Pharmacology (12.4) ] .
Ramelteon is not recommended in patients with severe hepatic impairment.
8.9 Renal Impairment No effects on C max and AUC 0-t of parent drug or M-II were seen.
No adjustment of ramelteon dosage is required in patients with renal impairment [see Clinical Pharmacology (12.4) ] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Rifampin (strong CYP enzyme inducer): Decreases exposure to and effects of ramelteon.
( 7.1 ) Ketoconazole (strong CYP3A4 inhibitor):
Increases AUC for ramelteon; administer with caution.
( 7.1 ) Fluconazole (strong CYP2C9 inhibitor):
Increases systemic exposure of ramelteon; administer with caution.
( 7.1 ) Donepezil:
Increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with donepezil.
( 7.1 ) Doxepin:
Increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with doxepin.
( 7.1 ) Alcohol:
Causes additive psychomotor impairment; should not be used in combination.
( 7.2 )
7.1 Effects of Other Drugs on Ramelteon Fluvoxamine (strong CYP1A2 inhibitor) AUC 0-inf for ramelteon increased approximately 190-fold, and the C max increased approximately 70- fold upon coadministration of fluvoxamine and ramelteon, compared to ramelteon administered alone.
Ramelteon should not be used in combination with fluvoxamine [see Contraindications (4), Clinical Pharmacology (12.5) ] .
Other less strong CYP1A2 inhibitors have not been adequately studied.
Ramelteon should be administered with caution to patients taking less strong CYP1A2 inhibitors.
Rifampin (strong CYP enzyme inducer) Administration of multiple doses of rifampin resulted in a mean decrease of approximately 80% in total exposure to ramelteon and metabolite M-II.
Efficacy may be reduced when ramelteon is used in combination with strong CYP enzyme inducers such as rifampin [see Clinical Pharmacology (12.5) ] .
Ketoconazole (strong CYP3A4 inhibitor) The AUC 0-inf and C max of ramelteon increased by approximately 84% and 36% upon coadministration of ketoconazole with ramelteon.
Ramelteon should be administered with caution in subjects taking strong CYP3A4 inhibitors such as ketoconazole [see Clinical Pharmacology (12.5) ] .
Fluconazole (strong CYP2C9 inhibitor) The AUC 0-inf and C max of ramelteon was increased by approximately 150% when ramelteon was coadministered with fluconazole.
Ramelteon should be administered with caution in subjects taking strong CYP2C9 inhibitors such as fluconazole [see Clinical Pharmacology (12.5) ] .
Donepezil The AUC 0-inf and C max of ramelteon increased by approximately 100% and 87%, respectively upon coadministration of donepezil with ramelteon.
Patients should be closely monitored when ramelteon is coadministered with donepezil [see Clinical Pharmacology (12.5) ] .
Doxepin The AUC 0-inf and C max of ramelteon increased by approximately 66% and 69%, respectively, upon coadministration of doxepin with ramelteon.
Patients should be closely monitored when ramelteon is coadministered with doxepin [see Clinical Pharmacology (12.5) ] .
7.2 Effect of Alcohol on Ramelteon Alcohol by itself impairs performance and can cause sleepiness.
Since the intended effect of ramelteon is to promote sleep, patients should be cautioned not to consume alcohol
when using ramelteon [see Clinical Pharmacology (12.5) ] .
Use of the products in combination may have an additive effect.
7.3 Drug/Laboratory Test Interactions Ramelteon is not known to interfere with commonly used clinical laboratory tests.
In addition, in vitro data indicate that ramelteon does not cause false-positive results for benzodiazepines, opiates, barbiturates, cocaine, cannabinoids, or amphetamines in two standard urine drug screening methods in vitro .

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

General symptomatic and supportive measures should be used, along with immediate gastric lavage where appropriate.
Intravenous fluids should be administered as needed.
As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate vital signs should be monitored, and general supportive measures employed.
Hemodialysis does not effectively reduce exposure to ramelteon.
Therefore, the use of dialysis in the treatment of overdosage is not appropriate.
Poison Control Center As with the management of all overdosage, the possibility of multiple drug ingestion should be considered.
Contact a poison control center for current information on the management of overdosage.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Ramelteon is not a controlled substance.
Discontinuation of ramelteon in animals or in humans after chronic administration did not produce withdrawal signs.
Ramelteon does not appear to produce physical dependence.
Human Data A laboratory abuse potential study was performed with ramelteon [see Clinical Studies (14.2)].
Animal Data Ramelteon did not produce any signals from animal behavioral studies indicating that the drug produces rewarding effects.
Monkeys did not self-administer ramelteon and the drug did not induce a conditioned place preference in rats.
There was no generalization between ramelteon and midazolam.
Ramelteon did not affect rotorod performance, an indicator of disruption of motor function, and it did not potentiate the ability of diazepam to interfere with rotorod performance.

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

Safety and effectiveness of ramelteon in pediatric patients have not been established. Further study is needed prior to determining that this product may be used safely in prepubescent and pubescent patients.

Quoted from the official label, section “Pediatric Use”.

Use in older people

A total of 654 subjects in double-blind, placebo-controlled, efficacy trials who received ramelteon were at least 65 years of age; of these, 199 were 75 years of age or older.
No overall differences in safety or efficacy were observed between elderly and younger adult subjects.
A double-blind, randomized, placebo-controlled study in elderly subjects with insomnia (n=33) evaluated the effect of a single dose of ramelteon on balance, mobility, and memory functions after middle of the night awakening.
There is no information on the effect of multiple dosing.
Night time dosing of ramelteon 8 mg did not impair middle of the night balance, mobility, or memory functions relative to placebo.
The effects on night balance in the elderly cannot be definitively known from this study.

Quoted from the official label, section “Geriatric Use”.

Side effects

The following serious adverse reactions are discussed in greater detail in other sections:
Severe anaphylactic and anaphylactoid reactions [see Warnings and Precautions (5.1) ] Abnormal thinking, behavior changes, and complex behaviors [see Warnings and Precautions (5.3) ] CNS effects [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥3% and more common than with placebo) are:
somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Adverse Reactions Resulting in Discontinuation of Treatment The data described in this section reflect exposure to ramelteon in 5373 subjects, including 722 exposed for six months or longer, and 448 subjects for one year.
Six percent of the 5373 individual subjects exposed to ramelteon in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 2279 subjects receiving placebo.
The most frequent adverse events leading to discontinuation in subjects receiving ramelteon were somnolence, dizziness, nausea, fatigue, headache, and insomnia; all of which occurred in 1% of the patients or less.
Ramelteon Most Commonly Observed Adverse Events Table 1 displays the incidence of adverse events reported by the 2861 patients with chronic insomnia who participated in placebo-controlled trials of ramelteon.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of other drugs, and may not reflect the rates observed in practice.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Table 1.
Incidence (% of subjects) of Treatment-Emergent Adverse Events MedDRA Preferred Term Placebo (n=1456) Ramelteon 8 mg (n=1405) Somnolence 2% 3% Fatigue 2% 3% Dizziness 3% 4% Nausea 2% 3% Insomnia exacerbated 2% 3%

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Severe Anaphylactic and Anaphylactoid Reactions Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with ramelteon.
Describe the relevant signs/symptoms and advise seeking immediate medical attention if any such things occur.
Sleep-Driving and other Complex Behaviors There have been reports of people getting out of bed after taking a sleep medication and driving their cars while not fully awake, often with no memory of the event.
If a patient experiences such an episode, it should be reported to his or her doctor immediately, since "sleep-driving" can be dangerous.
This behavior is more likely to occur when sleep medications are taken with alcohol or other central nervous system depressants.
Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sleep medication.
As with sleep-driving, patients usually do not remember these events.
Endocrine Effects Patients should consult their healthcare providers if they experience one of the following:
cessation of menses or galactorrhea in females, decreased libido, or problems with fertility.
Describe the relevant signs/symptoms and advise seeking medical attention if any such things occur.
Administration Instructions Patients should be advised to take ramelteon tablets within 30 minutes prior to going to bed and should confine their activities to those necessary to prepare for bed.
Patients should be advised that they should not take ramelteon tablets with or immediately after a high-fat meal.
Do not break the tablet; it should be swallowed whole.
Lactation Advise mothers using ramelteon tablets to monitor neonates for signs of somnolence and feeding problems.
A lactating woman may consider pumping and discarding breast milk during treatment and for 25 hours after ramelteon tablets administration to minimize drug exposure to a breastfed infant [see Use in Specific Populations (8.2) ] .
Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides .
Repackaged and Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Ramelteon tablets are available in an 8 mg strength tablet for oral administration.
Ramelteon tablets, 8 mg are pale yellow colored, round, biconvex film-coated tablets, debossed with “RT” on one side and “8” on the other side. 8 mg tablets.
( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Ramelteon Tablets 8 mg are available as pale yellow colored, round, biconvex film-coated tablets, debossed with “RT” on one side and “8” on the other side.
They are supplied as follows:
Bottles of 30 NDC 76420-880-30 (relabeled from NDC 59651-505-30) Bottles of 60 NDC 76420-880-60 (relabeled from NDC 59651-505-XX) Bottles of 90 NDC 76420-880-90 (relabeled from NDC 59651-505-XX) Bottles of 100 NDC 76420-880-01 (relabeled from NDC 59651-505-01)
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Keep container tightly closed and protected from moisture and humidity.

Quoted from the official label, section “How Supplied”.

What is in it

Ramelteon is an orally active hypnotic chemically designated as ( S )- N -[2-(1,6,7,8- tetrahydro-2 H -indeno-[5,4- b ]furan-8-yl)ethyl]propionamide and containing one chiral center.
The compound is produced as the ( S )-enantiomer, with the molecular formula of C 16 H 21 NO 2 , molecular weight of 259.34, and the following chemical structure:
Ramelteon is white to off-white powder soluble in methanol and practically insoluble in water.
Each ramelteon tablet includes the following inactive ingredients:
copolyvidone, hyperomellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), and titanium dioxide. str

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.
Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (31)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 31 of 31

Details

Made by	Asclemed USA, Inc.
Active substance	Ramelteon
Strength	8 mg
Form	Tablet, Film Coated
Route	Oral
Packs	100 TABLET, FILM COATED in 1 BOTTLE · 30 TABLET, FILM COATED in 1 BOTTLE
NDC	76420-880

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

30 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet16 products
- 8 mg16
  8 mg · 16 companies
  +8 more
Tablet, Film Coated14 products
- 8 mg14
  8 mg · 14 companies
  - Advanced Rx Pharmacy of Tennessee, LLC
  - Asclemed USA, Inc. · this page
  - Aurobindo Pharma Limited
  - Bryant Ranch Prepack
  - Direct_Rx
  - Golden State Medical Supply, Inc.
  - i3 Pharmaceuticals, LLC
  - Kanchan Healthcare Inc
  +6 more

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Ramelteon8 mgPrescription onlyTablet Actavis Pharma, Inc. · Ramelteon Ramelteon8 mgPrescription onlyTablet, Film Coated Upsher-Smith Laboratories, LLC · Ramelteon Ramelteon8 mgPrescription onlyTablet Major Pharmaceuticals · Ramelteon Ramelteon8 mgPrescription onlyTablet, Film Coated Marlex Pharmaceuticals, Inc. · Ramelteon Ramelteon8 mgPrescription onlyTablet AvKARE · Ramelteon Ramelteon8 mgPrescription onlyTablet Micro Labs Limited · Ramelteon

See every product with Ramelteon