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Ramelteon

Ramelteon is a sleep medicine (a melatonin receptor agonist) used to treat insomnia when the main problem is trouble falling asleep.

Brand name Rozerem
Drug class Melatonin Receptor Agonist
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 45 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

Ramelteon at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Ramelteon (Rozerem) treats insomnia when falling asleep is the main problem, working on the brain's melatonin receptors rather than the GABA system many sleep medicines target, and it is often picked when habit-forming options are a worry; it has been on the market since about 2005 and is available as a generic. Most people tolerate it well, noticing at most some drowsiness, dizziness or tiredness, and its push toward sleep is gentle rather than knockout strength. Get emergency help for any swelling of the tongue or throat (angioedema), and report sleep-driving or other things done while not fully awake.

Clinical pearls

  • Take it within 30 minutes of bedtime, not with or right after a high-fat meal, and avoid alcohol.
  • Never combine it with fluvoxamine, which raises ramelteon levels enormously, and mention fluconazole, ketoconazole or rifampin to anyone prescribing it.
  • If you still struggle to fall asleep after 7 to 10 days, get checked, since lasting insomnia can signal another problem.
  • Report missed periods, milky breast discharge or lower sex drive, because ramelteon can shift reproductive hormones.
How you get itPrescription only
Comes asTablet
Earliest FDA record2005
Companies listing it with the FDA26
FDA label last updatedApr 15, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Ramelteon, written from its FDA label.

What Ramelteon is used for

▾

Ramelteon is used for one condition:

  • Insomnia characterized by difficulty with sleep onset (trouble falling asleep). This applies to Rozerem and to ramelteon tablets, including film-coated tablets.

How Ramelteon works

▾

Ramelteon is a melatonin receptor agonist. It attaches to the MT1 and MT2 receptors that your body's own melatonin uses. These receptors help keep the normal sleep-wake cycle (circadian rhythm) on track.

It does not act on the GABA receptor complex or on receptors for serotonin, dopamine, acetylcholine or opiates.

Ramelteon dosage

▾

Ramelteon is a tablet taken by mouth, once nightly, within 30 minutes of bedtime. Avoid taking it with or right after a high-fat meal, since food slows and changes how it is absorbed.

  • Don't exceed the maximum daily amount on your label.
  • Follow your prescriber's directions and your product label.

Dosing details from the FDA-approved label

From the Ramelteon prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adults
    • 8 mg taken within 30 minutes of going to bed
    • Maximum: The total dose should not exceed 8 mg per day
    • Should not be taken with or immediately after a high-fat meal
  • Patients with hepatic impairment
    • Not recommended in patients with severe hepatic impairment
    • Should be used with caution in patients with moderate hepatic impairment
    • Severe hepatic impairment: not recommended; moderate: use with caution
  • Administration with other medications
    • Should not be used in combination with fluvoxamine
    • Should be used with caution in patients taking other CYP1A2 inhibiting drugs
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • 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 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) ] .

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 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) ] .

Read the full Dosage and Administration section on DailyMed →

Ramelteon side effects

▾

Most people tolerate ramelteon well. Common side effects include:

Common side effects

  • Sleepiness (somnolence)
  • Dizziness
  • Tiredness (fatigue)
  • Nausea
  • Worsening of insomnia

When to get medical help

  • Get emergency help if your tongue, throat or voice box swells, or you have trouble breathing, throat closing, or nausea and vomiting after a dose. These can be signs of angioedema or a severe allergic reaction.
  • Call your doctor right away if you do complex things while not fully awake, such as sleep-driving, cooking and eating, making phone calls or having sex, and you don't remember it.
  • Call your doctor if you notice hallucinations, bizarre behavior, agitation, mania, or new memory or anxiety problems.
  • Call your doctor if depression gets worse or you have thoughts of suicide.
  • Call your doctor if your insomnia gets worse or hasn't improved after 7 to 10 days.
  • Tell your doctor about unexplained missed periods, milk discharge from the breasts, lower sex drive or fertility problems. Ramelteon can change reproductive hormones.

Ramelteon warnings and precautions

▾
  • Severe allergic reaction (angioedema/anaphylaxis): rare, but can block the airway. Don't take ramelteon again if it happens.
  • Complex sleep behaviors: sleep-driving or other activities with no memory of them. Stopping the drug should be strongly considered.
  • Mood and thinking changes: hallucinations, agitation, mania, and worsening depression or suicidal thoughts.
  • Next-day alertness: avoid driving or hazardous tasks after a dose.
  • Hormone effects: lower testosterone and higher prolactin have been seen.
  • Persistent insomnia: if it doesn't improve in 7 to 10 days, see your doctor.

Ramelteon interactions

▾

Several medicines and alcohol can change how ramelteon works or how safe it is.

  • Fluvoxamine: must not be combined; it greatly raises ramelteon levels.
  • Alcohol: adds to impairment and sleepiness.
  • Rifampin: lowers ramelteon levels, so it may not work as well.
  • Ketoconazole, fluconazole: raise ramelteon levels; use with caution.
  • Donepezil, doxepin: raise ramelteon levels; close monitoring needed.
  • Other CYP1A2 inhibitors: use with caution.

Interactions listed in the FDA-approved label

From the Ramelteon prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Fluvoxamine (strong CYP1A2 inhibitor): AUC 0-inf for ramelteon increased approximately 190-fold, and the Cmax increased approximately 70-fold, compared to ramelteon administered alone. Should not be used in combination with fluvoxamine.
  • Other less strong CYP1A2 inhibitors: Have not been adequately studied. Should be administered with caution to patients taking less strong CYP1A2 inhibitors.
  • Rifampin (strong CYP enzyme inducer): 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. Efficacy may be reduced when used in combination with strong CYP enzyme inducers such as rifampin.
  • Ketoconazole (strong CYP3A4 inhibitor): AUC 0-inf and Cmax of ramelteon increased by approximately 84% and 36%. Administer with caution in subjects taking strong CYP3A4 inhibitors such as ketoconazole.
  • Fluconazole (strong CYP2C9 inhibitor): AUC 0-inf and Cmax of ramelteon were increased by approximately 150%. Administer with caution in subjects taking strong CYP2C9 inhibitors such as fluconazole.
  • Donepezil: AUC 0-inf and Cmax of ramelteon increased by approximately 100% and 87%, respectively. Patients should be closely monitored when coadministered with donepezil.
  • Doxepin: AUC 0-inf and Cmax of ramelteon increased by approximately 66% and 69%, respectively. Patients should be closely monitored when coadministered with doxepin.
  • Alcohol: Alcohol by itself impairs performance and can cause sleepiness; use in combination may have an additive effect. Patients should be cautioned not to consume alcohol when using ramelteon; should not be used in combination.
Read the label’s full interactions text

7 DRUG 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 co-administered with donepezil. (7.1) Doxepin: Increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is co-administered 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 Tablets, compared to Ramelteon Tablets 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 Tablets. Ramelteon Tablets should be administered with caution in subjects taking strong CYP3A4 inhibitors such as ketoconazole [see Clinical Pharmacology (12.5) ].

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Ramelteon

▾
  • Don't use if you've had angioedema on ramelteon.
  • Tell your prescriber if you take fluvoxamine.
  • Severe liver impairment: not recommended. Moderate: use caution.
  • Severe sleep apnea: not recommended.
  • Pregnancy: discuss with your prescriber.
  • Breastfeeding: the baby should be watched for sleepiness and feeding problems.
  • Children: safety and effectiveness not established.
  • Older adults: no overall differences in safety or effectiveness seen.

Ramelteon overdose

▾

The label advises general supportive care, monitoring of breathing, pulse and blood pressure, and fluids as needed. Dialysis does not effectively remove ramelteon. Contact a poison control center right away if too much is taken.

What Ramelteon does in the body

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Ramelteon activates melatonin MT1 and MT2 receptors, which are thought to help maintain the sleep-wake cycle. Its main breakdown product, M-II, is also active but binds more weakly. It does not bind appreciably to GABA, serotonin, dopamine or opiate receptors.

How your body processes Ramelteon

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Ramelteon is absorbed quickly, peaking in about 45 minutes when taken fasted. The liver breaks most of it down before it reaches the bloodstream, mainly using the CYP1A2 enzyme. Its half-life is short, about 1 to 2.6 hours, so it doesn't build up with daily use. Most of it leaves in the urine as metabolites, and elimination is essentially complete within 96 hours. A high-fat meal delays and changes absorption.

How to store Ramelteon

▾

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

228

Supplements & herbs that interact with Ramelteon

228 supplements and herbal products have documented interactions with Ramelteon in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 9
  • Moderate · 173
  • Minor · 46
Every supplement checked against Ramelteon — ranked by severity The full interaction hub: 9 major · 173 moderate · 46 minor · every one linked to its full report. Check Ramelteon against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Ramelteon: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Ramelteon — the kind of thing our pharmacy team would talk through with you at the counter.

What is ramelteon for?

▾
It treats insomnia when your main trouble is falling asleep. It works on melatonin receptors in the brain that help regulate your sleep-wake cycle.

When and how should I take it?

▾
Take one tablet by mouth within 30 minutes of going to bed. Don't take it with or right after a high-fat meal, since that changes how it's absorbed. Follow your prescriber's directions and don't exceed the daily maximum.

What side effects should I expect?

▾
The more common ones are sleepiness, dizziness, tiredness, nausea and worsening insomnia. Avoid driving or other risky tasks after your dose. Do only what you need to get ready for bed.

When should I call my doctor or get emergency help?

▾
Get emergency help for swelling of the tongue, throat or face, or trouble breathing. Call your doctor if you do things like drive or cook while asleep, see things that aren't there, feel more depressed, or still can't sleep after 7 to 10 days.

Can I drink alcohol or take other medicines with it?

▾
Skip alcohol, since it adds to the sleepiness and impairment. Never combine ramelteon with fluvoxamine. Tell me about any other medicines you take, like rifampin, ketoconazole, fluconazole, donepezil or doxepin, because they can change ramelteon levels.

Is it safe in pregnancy or while breastfeeding?

▾
Reports so far haven't shown a clear pregnancy risk, but animal studies showed harm at high doses, so talk with your prescriber. Ramelteon may pass into breast milk and make a baby sleepy. Your prescriber can help you weigh the options.

Is Ramelteon available over the counter?

▾
No. Ramelteon is a prescription medicine: every Ramelteon product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Ramelteon first available?

▾
The earliest FDA record we hold for Ramelteon is from 2005: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Ramelteon was first used.

Who makes Ramelteon?

▾
26 companies currently list Ramelteon products in the FDA's NDC Directory, including Bryant Ranch Prepack, Asclemed USA, Inc., Direct_Rx. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Ramelteon on HelloPharmacist

Detailed data & references for Ramelteon Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Ramelteon forms and strengths (how it comes)

Ramelteon is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Rozerem
How this form is used
What it may be used for
  • Rozerem is used to treat insomnia with difficulty falling asleep.
  • Ramelteon tablets are used to treat insomnia with difficulty falling asleep.
Important instructions
  • Rozerem is taken within 30 minutes of going to bed and not with or right after a high-fat meal.
  • Ramelteon tablets are taken within 30 minutes of going to bed and not with or right after a high-fat meal.
  • Rozerem and ramelteon tablets should not be used with fluvoxamine.
Available strengths 1 strength
74 FDA-listed product records ⓘ

Ramelteon on the U.S. market: products, makers and brands

How Ramelteon appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

26 companies list 41 Ramelteon product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2005. Brand names on the directory include Rozerem; the rest are generics.

1
Dose forms ⓘ
26
Labelers (makers, repackagers, distributors)
2
Brand names
41
FDA-listed product records ⓘ
2005
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (11) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack24%
Asclemed USA, Inc.7%
Direct_Rx7%
Advanced Rx Pharmacy of Tennessee, LLC5%
Proficient Rx LP5%
Actavis Pharma, Inc.2%
Other makers49%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Ramelteon is used (Medicaid data)

A general measure of how commonly Ramelteon is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Ramelteon is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

138,690
Medicaid prescriptions filled (Q1–Q4 2025)
$9.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ramelteon prescribed? Of the 1,601 medications we measure, Ramelteon ranks #454 by Medicaid prescriptions — more than 72% of them.

Where Ramelteon ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Ramelteon product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

ramelteon 8 MG Oral Tablet

138,690 Medicaid prescriptions (Q1–Q4 2025) 100% of Ramelteon prescriptions shown $9.9M gross reimbursement (before rebates) ≈ $72 per prescription (gross)

Summed across the 21 of 103 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 577348

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ramelteon, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 21 of 103 listed Ramelteon NDCs with Medicaid activity.

Compare Ramelteon products

A representative set of FDA-listed product records for Ramelteon — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 41 of 41 products — FDA National Drug Code Directory. See every product, package size and price: browse all 41 Ramelteon NDCs →

Ramelteon side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ramelteon — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Ramelteon are initial insomnia, somnolence, insomnia; about 55% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

7,348
Reports mentioning it
55%
Reported as serious
12
Distinct effects shown
Most reported effects
Initial Insomnia
447
Somnolence
418
Insomnia
398
Middle Insomnia
390
Nausea
337
Fatigue
288
Dizziness
274
Headache
261
Diarrhoea
220
Poor Quality Sleep
218
Age groups
Elderly · 373Adult · 283Child · 12Adolescent · 8Infant · 2Neonate · 1

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ramelteon in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Ramelteon FDA approval history

How Ramelteon went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Ramelteon was first approved by the FDA in 2005 (Brand: ROZEREM · Takeda Pharms Usa); the first generic version was approved in 2013. It remains available in U.S. pharmacies today.

2005
Brand approved
Brand: ROZEREM · Takeda Pharms Usa
2013
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Ramelteon recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Ramelteon recalls since July 2021.

✅No Ramelteon recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ramelteon RxCUI 596205 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Tablet RxCUI 577347 In current FDA listings
    Clinical drug / strength (SCD) 8 MG RxCUI 577348

Look up RxCUI 596205 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Ramelteon supply and shortage status

Whether Ramelteon is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.

Ramelteon is not in shortage right now; the FDA has 2 past shortage records for it.

✅No current shortage of Ramelteon on record
To be discontinued Rozerem, Tablet, 8 mg (NDC 64764-805-10)
Takeda Pharmaceuticals USA Inc. · Since 03/19/2026 · Updated 03/19/2026
To be discontinued Rozerem, Tablet, 8 mg (NDC 64764-805-30)
Takeda Pharmaceuticals USA Inc. · Since 03/19/2026 · Updated 03/19/2026

Source: openFDA, from the FDA Drug Shortages database.

💵 What Ramelteon costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 8 mg $0.660 per tablet NDC details & price history
Tablet · Oral 8 mg $0.660 per tablet NDC details & price history
Tablet 8 mg $0.660 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Ramelteon brand names

Ramelteon is sold under one brand name in the FDA directory — Rozerem. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Rozerem

Who makes Ramelteon: manufacturers and labelers

26 companies list Ramelteon products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Asclemed USA, Inc., Direct_Rx. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 10 Asclemed USA, Inc. 3 Direct_Rx 3 Advanced Rx Pharmacy of Tennessee, LLC 2 Proficient Rx LP 2 Actavis Pharma, Inc. 1 Advanced Rx of Tennessee, LLC 1 American Health Packaging 1 Aurobindo Pharma Limited 1 AvKARE 1 AvPAK 1 Golden State Medical Supply, Inc. 1 Granules Pharmaceuticals Inc. 1 Kanchan Healthcare Inc 1 Major Pharmaceuticals 1 Marlex Pharmaceuticals, Inc. 1 Micro Labs Limited 1 Remedyrepack Inc. 1 Sportpharm LLC 1 Takeda Pharmaceuticals America, Inc. 1 TruPharma, LLC 1 Upsher-Smith Laboratories, LLC 1 Xiromed, LLC 1 Zydus Lifesciences Limited 1

…and 2 more on the FDA NDC directory.

Ramelteon drug class (RxNorm)

Ramelteon belongs to the Melatonin Receptor Agonist class.

Pharmacologic class Melatonin Receptor Agonist
Drug family (ATC) Melatonin receptor agonists
How it works Melatonin Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Ramelteon page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 15, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ramelteon.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ramelteon after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
45
Finished products in the current FDA directory
41
Companies listing them (makers, repackagers, distributors)
26
FDA labeler codes behind them ⓘ
29
Linked representative label ⓘ
Takeda Pharmaceuticals America, Inc.
Linked label effective
Apr 15, 2026
Composite sections available
23
Linked SPL Set ID
9de82310-70e8-47b9-b1fc-6c6848b99455
Linked SPL Document ID
2021e7fb-108a-4783-9a37-8bc05bf28b28
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Takeda Pharmaceuticals America, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →