Quick answers
- What is Ramelteon used for?
- The FDA-approved label (Rozerem, Takeda Pharmaceuticals America, Inc., April 15, 2026) says: “ROZEREM ® 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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ramelteon have a boxed warning?
- No. None of the 40 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ramelteon?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated March 19, 2026). Ask your pharmacist about alternatives.
- Has Ramelteon been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ramelteon?
- 26 companies list prescription products of Ramelteon in the FDA NDC Directory, including Bryant Ranch Prepack, Asclemed USA, Inc. and Direct_Rx.
What Ramelteon is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ROZEREM ® 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 …
— FDA label: Rozerem, Takeda Pharmaceuticals America, Inc., effective April 15, 2026. Read the full label on DailyMed →
The FDA has 40 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 40 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 41 in the FDA NDC Directory |
| Brand names | Rozerem |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ramelteon 8 mg tablet | Generic | $0.6660 per tablet |
| ramelteon 8 mg tablet, film coated | Generic | $0.6660 per tablet |
| ramelteon 8 mg tablet, film coated | Brand: Rozerem | $12.41 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack10 products
- Asclemed USA, Inc.3 products
- Direct_Rx3 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Proficient Rx LP2 products
- Actavis Pharma, Inc.1 product
- Zydus Lifesciences Limited1 product
- i3 Pharmaceuticals, LLC1 product
- Kanchan Healthcare Inc1 product
- Golden State Medical Supply, Inc.1 product
- Remedyrepack Inc.1 product
- Major Pharmaceuticals1 product
- Takeda Pharmaceuticals America, Inc.1 product
- Upsher-Smith Laboratories, LLC1 product
- Sportpharm LLC1 product
- Marlex Pharmaceuticals, Inc.1 product
- AvPAK1 product
- American Health Packaging1 product
- Xiromed, LLC1 product
- Micro Labs Limited1 product
- Aurobindo Pharma Limited1 product
- AvKARE1 product
- Advanced Rx of Tennessee, LLC1 product
- TruPharma, LLC1 product
- Granules Pharmaceuticals Inc.1 product
- Zydus Pharmaceuticals USA Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021782 ROZEREM | Takeda Pharms USA | July 22, 2005 | 13, latest November 3, 2021 2021: Labeling · 2018: Labeling · 2016: Manufacturing (CMC) |
Generic approvals (10)
- ANDA091693DR Reddys Labs SA · July 26, 2013
- ANDA091610Actavis Labs Fl Inc · August 19, 2015
- ANDA211567Zydus Pharms · July 22, 2019
- ANDA212650Pharmazone · April 10, 2020
- ANDA213186Granules · August 21, 2020
- ANDA213815Appco · October 26, 2020
- ANDA215435Andas 5 Holding · August 24, 2022
- ANDA216209Xiromed · November 25, 2022
- ANDA215243Micro Labs · February 9, 2023
- ANDA215972Aurobindo Pharma Ltd · July 10, 2023
Shortage status
To be discontinued · updated March 19, 2026 · first posted March 19, 2026
| Product | Rozerem, Tablet, 8 mg (NDC 64764-805-30) |
|---|---|
| Company | Takeda Pharmaceuticals USA Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 577348, 603162 |
|---|---|
| SPL set ID of the quoted label | 9de82310-70e8-47b9-b1fc-6c6848b99455 |
| FDA labels (SPL) | 40 |
| FDA applications | NDA021782, 10 ANDA |
| Active ingredients (FDA) | RAMELTEON |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Rozerem, Takeda Pharmaceuticals America, Inc., effective April 15, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →