Prescription medicine
Ramelteon Brand names: Rozerem
Ramelteon (Rozerem) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 27 generic labelers, and pharmacies paid $0.660 per ramelteon 8 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the ramelteon FDA label on DailyMed (effective April 15, 2026, Takeda Pharmaceuticals America, Inc.); the NDA 21782 record on Drugs@FDA; every ramelteon label on DailyMed.
Highlights of the record
FDA label of April 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageROZEREM ® is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
Forms and strengths
- 8 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- July 22, 2005 Rozerem, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first July 26, 2013; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 28 of which 27 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.660 per tablet Ramelteon 8 mg tablet
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 7,347 through July 30, 2026
What is ramelteon used for?
From the label: indications and usageROZEREM ® is 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) ]. ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
Conditions named in the indications of ramelteon's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Melatonin Receptor Agonist.
Source: FDA drug label (Rozerem), Takeda Pharmaceuticals America, Inc., effective April 15, 2026 (SPL set 9de82310-70e8-47b9-b1fc-6c6848b99455), via openFDA; the full label on DailyMed
What does the patient leaflet for ramelteon say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ROZEREM?ROZEREM may cause severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking ROZEREM. After taking ROZEREM, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with ROZEREM. Activities may include: driving a car ("sleep-driving") making and eating food talking on the phone having sex sleep-walking Call your doctor right away if you find out that you have done any of the above activities after taking ROZEREM. Important: 1. Take ROZEREM exactly as prescribed Do not take more ROZEREM than prescribed. Take ROZEREM within 30 minutes of going to bed, not sooner. 2. Do not take ROZEREM if you: drink alcohol take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take ROZEREM with your other medicines cannot get a full night's sleep WHAT IS ROZEREM? ROZEREM is a hypnotic (sleep) medicine. ROZEREM is used in adults for the treatment of the symptom of trouble falling asleep from insomnia. ROZEREM is not for children. Who should not take ROZEREM? Do not take ROZEREM if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in ROZEREM. Do not take ROZEREM if you are currently taking Luvox (fluvoxamine). ROZEREM may not be right for you. […]
From the patient leaflet: How should I Store ROZEREM?Store ROZEREM tablets at room temperature, 59° to 86° F (15° to 30°C). Keep the container tightly closed and protected from moisture and humidity. Keep ROZEREM and all medicines out of reach of children. General Information about ROZEREM Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ROZEREM for a condition for which it was not prescribed. Do not share ROZEREM with other people, even if you think they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about ROZEREM. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ROZEREM that is written for healthcare professionals. […]
Source: FDA drug label (Rozerem), Takeda Pharmaceuticals America, Inc., effective April 15, 2026 (SPL set 9de82310-70e8-47b9-b1fc-6c6848b99455), via openFDA; the full label on DailyMed
Is there a generic for ramelteon (Rozerem)?
The FDA approved the first generic ramelteon on July 26, 2013. 11 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ramelteon from 27 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2005 earliest approval on file
- 2013 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ramelteon (Rozerem)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.660 per Ramelteon 8 mg tablet, down 11% from $0.744 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ramelteon 8 mg tablet (generic)
- Rozerem 8 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ramelteon 8 mg tablet | Generic | $0.660 per tablet | $19.79 | -11% |
| Rozerem 8 mg tablet | Brand | $12.42 per tablet | $372.51 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is ramelteon in shortage?
No ramelteon presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated March 19, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Rozerem, Tablet, 8 mg (NDC 64764-805-10) | Takeda Pharmaceuticals USA Inc. | To Be Discontinued | March 19, 2026 |
| Rozerem, Tablet, 8 mg (NDC 64764-805-30) | Takeda Pharmaceuticals USA Inc. | To Be Discontinued | March 19, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the ramelteon label say about other medicines?
The ramelteon label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name ramelteon. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cocaine | drug interactions | 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. |
| Donepezil | drug interactions | 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. |
| Doxepin | drug interactions | Increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with doxepin. |
| Fluconazole | drug interactions | Increases AUC for ramelteon; administer with caution. ( 7.1 ) Fluconazole (strong CYP2C9 inhibitor): |
| Fluvoxamine | contraindications | Patients should not take ROZEREM in conjunction with fluvoxamine [see Drug Interactions (7) ]. |
| Ketoconazole | drug interactions | DRUG INTERACTIONS Rifampin (strong CYP enzyme inducer): Decreases exposure to and effects of ramelteon. ( 7.1 ) Ketoconazole (strong CYP3A4 inhibitor): |
| Rifampin | drug interactions | DRUG INTERACTIONS Rifampin (strong CYP enzyme inducer): Decreases exposure to and effects of ramelteon. ( 7.1 ) Ketoconazole (strong CYP3A4 inhibitor): |
| Testosterone | warnings and precautions | 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. |
Other labels that name ramelteon
Source: FDA drug label (Rozerem), Takeda Pharmaceuticals America, Inc., effective April 15, 2026 (SPL set 9de82310-70e8-47b9-b1fc-6c6848b99455), via openFDA; the full label on DailyMed
What do FAERS reports show for ramelteon?
The FDA Adverse Event Reporting System holds 7,347 reports that list ramelteon among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 802 are coded as a death and 2,087 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ramelteon?
11 other medicines are given the same way (oral) and in the same FDA class as ramelteon or labeled mainly for the same use (insomnia), the same class first. Insomnia lists all 14 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Zolpidem | Insomnia | 39 labelers | $0.0344 per tablet 5 mg tablet | No current entry |
| Eszopiclone | Insomnia | 26 labelers | $0.0993 per tablet 1 mg tablet | No current entry |
| Temazepam | Insomnia | 20 labelers | $0.0767 per capsule 15 mg capsule | No current entry |
| Zaleplon | Insomnia | 9 labelers | $0.141 per capsule 10 mg capsule | No current entry |
| Triazolam | Insomnia | 7 labelers | $0.308 per tablet 0.25 mg tablet | No current entry |
| Estazolam | Insomnia | 3 labelers | $0.839 per tablet 2 mg tablet | No current entry |
| Suvorexant | Insomnia | none listed | $15.21 per tablet 10 mg tablet | No current entry |
| Daridorexant | Insomnia | none listed | $16.70 per tablet 25 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ramelteon compare with medicines for the same use?
4 side-by-side pages set ramelteon beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ramelteon
- 11 medicines for the same use
- Other melatonin receptor agonists
- the pharmacologic class, with prices and generics
- Ramelteon side effects
- the label's list beside FAERS reports
- Ramelteon shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other