ramelteon
Pharmaranks rates Ramelteon 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Ramelteon is a melatonin receptor agonist used to treat Sleep Initiation and Maintenance Disorders.
Melatonin Receptor Agonist · by Granules
Generic of Rozerem
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Ramelteon
- Drug class
- Melatonin Receptor Agonist
- Form
- Tablet
- Strength
- Ramelteon 8MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Granules
- What the pharmacy pays
- ~$21.45 for 30 — not your price
- FDA application
- ANDA213186
- Availability
- Discontinued (per FDA)
What is Ramelteon?
From the FDA label: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 an empirical formula of C 16 H 21 NO 2 , molecular weight of 259.34, and the following chemical structure: Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon tablet includes the following inactive ingredients: copovidone, corn starch, hydroxypropyl cellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide. ramelteon-structure-jpg
How to use
Dosage in Adults The recommended dose of ramelteon tablets is 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. • 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 ) 2.1 Dosage in Adults The recommended dose of ramelteon tablets is 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 Precaution ( 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 )]. 2.1 Dosage in Adults The recommended dose of ramelteon tablets is 8 mg taken within 30 minutes of going…
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 Granules Pharmaceuticals Inc., at 1-877-770-3183 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 tablets in 5,373 subjects, including 722 exposed for six months or longer and 448 subjects for one year. Six percent of the 5,373 individual subjects exposed to Ramelteon tablets in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 2,279 subjects receiving placebo. The most frequent adverse events leading to discontinuation in subjects receiving ramelteon tablets were somnolence, dizziness, nausea, fatigue, headache, and insomnia; all of which occurred in 1% of the patients or less. Ramelteon Tablets Most Commonly Observed Adverse Events Table 1 displays the incidence…
Warnings
Important safety information
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 tablets are 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 tablets. 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 tablets 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 tablets 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 tablets 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 tablets. Discontinuation of ramelteon tablets should be strongly considered for patients who report any complex sleep behavior. 5.4 CNS Effects Patients should avoid engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking ramelteon tablets. After taking ramelteon tablets, patients should confine their activities to those necessary to prepare for bed. Patients should be advised not to consume alcohol in combination with ramelteon tablets as alcohol and ramelteon tablets may have additive effects when used in conjunction. 5.5 Reproductive Effects Ramelteon tablets have 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 tablets may have on the reproductive axis in developing humans [see Clinical Trials (14.3) ]. 5.6 Use in Patients with Concomitant Illness Ramelteon tablets have not been studied in subjects with severe sleep apnea and are not recommended for use in this population [see Use in Specific Populations (8.7) ]. Ramelteon tablets 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 tablets are 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 .
Who should not take Ramelteon
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)
Overdose — what happens if you take too much
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 tablets. 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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
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 Tablets 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 tablets 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 tablets 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 tablets are 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 tablets 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 tablets 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 tablets are 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 tablets are coadministered with doxepin [see Clinical Pharmacology (12.5)] . 7.2 Effect of Alcohol on Ramelteon Tablets 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 tablets [see Clinical Pharmacology (12.5) ]. Use of the products in combination may have an additive effect. 7.3 Drug/Laboratory Test Interactions Ramelteon tablets are 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.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Ramelteon treat?
- Ramelteon (Ramelteon) may be used to treat sleep initiation and maintenance disorders, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Ramelteon rated?
- pharmaranks gives Ramelteon a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Ramelteon cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $21.45 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Ramelteon?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ramelteon. To pay less, Ramelteon is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ramelteon?
- Ramelteon is marketed by Granules. You can see Granules's full profile, rating, and other products on pharmaranks.
- Is Ramelteon a brand-name or generic drug?
- Ramelteon is a generic medication; its active ingredient is Ramelteon. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Ramelteon available over the counter?
- No. Ramelteon is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ramelteon come in?
- Ramelteon is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Ramelteon?
- Ramelteon is classified as melatonin receptor agonist, per the FDA's Established Pharmacologic Class.
- Is Ramelteon FDA-registered?
- Ramelteon is on record with the U.S. FDA under application number ANDA213186. You can verify this on its official FDA label.
- Has Ramelteon been recalled by the FDA?
- Ramelteon has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Ramelteon safe?
- There's no single safe-or-not verdict. pharmaranks gives Ramelteon a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Ramelteon?
- Ramelteon's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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ramelteon
72/100