Ramelteon Tablet shortage
Ramelteon Tablet is currently listed in shortage by the FDA. The FDA lists 2 affected products. This page was last refreshed from FDA data on Oct 1, 2026.
Rozerem (ramelteon) 8 mg tablets are being discontinued by Takeda. Other manufacturers, including Actavis Pharma, Upsher-Smith Laboratories, Major Pharmaceuticals, and AvKARE, still list generic ramelteon 8 mg as available.
Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).
Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →What’s in shortage — at a glance
These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Ramelteon Tablet. Other makers that haven’t reported a problem are shown in the green card below.
Shortage timeline
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Mar 19, 2026Currently in shortage2 of 2 products affected.
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Mar 19, 2026First reported to the FDA2 products first listed.
Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.
What exactly is on backorder — by manufacturer
Manufacturer: Takeda Pharmaceuticals USA Inc. 📞 877-825-3327 2 NDCS click to expand
| Status | NDC / product | Strength | Availability | Related information | Reason |
|---|---|---|---|---|---|
| To Be Discontinued | Rozerem, Tablet, 8 mg (NDC 64764-805-30) | — | — | Product is expected to be available through June 2027. | — |
| To Be Discontinued | Rozerem, Tablet, 8 mg (NDC 64764-805-10) | — | — | Product is expected to be available through February 2027. | — |
These rows are manufacturer reports to the FDA for Ramelteon Tablet — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Ramelteon Tablet? options further down this page.
Why is Ramelteon Tablet in shortage?
Takeda Pharmaceuticals has reported to the FDA that they will be permanently stopping production of Rozerem (ramelteon) 8 mg tablets. They haven't shared a specific public reason for this decision. The timing depends on the package size — the 10-count package is expected to be available through February 2027, while the 30-count package is expected to remain available through June 2027.
It's worth knowing that this report reflects only what Takeda has shared with the FDA about their own product. Other manufacturers may produce ramelteon and are listed separately on this page.
Based on the manufacturer-reported reason(s) and notes on file with the FDA for Ramelteon Tablet, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.
What should I do if I take Ramelteon Tablet?
Ramelteon (the brand Rozerem) is currently on the FDA shortage list, and the record notes it is being discontinued by the manufacturer who filed this report.
This medicine comes in one strength, 8 mg, and that is the strength affected. The report shows no available source from the filing manufacturer right now. Because the status is "to be discontinued," this particular supply problem may be permanent. That said, the manufacturer's notes indicate the branded product is expected to remain available through early-to-mid 2027, so this is a planned wind-down rather than a sudden stop. This report reflects only one manufacturer — other companies still make the same medicine.
Here is what I suggest, in order:
- Do not stop, skip, or change your dose on your own.
- Ask your pharmacy to check wholesalers and other suppliers for the 8 mg tablet; stock can vary by location.
- Ramelteon 8 mg is also made by several other manufacturers (for example Actavis, Upsher-Smith, Aurobindo, Granules, and others). Your pharmacy may be able to source one of these, though it may not be in local stock.
- Because this product is being discontinued, please talk with your prescriber or pharmacist about your long-term options.
Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle those calls.
This is general, national information and may not match your local pharmacy's actual stock.
- Don’t stop or change the medication on your own — talk to your prescriber first.
- If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
- Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
- Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.
Where else can I get Ramelteon Tablet?
FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Ramelteon Tablet is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.
Same medicine, other manufacturers (not reported short)
Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:
| Product | Strength | Form / route | Manufacturer | NDC |
|---|---|---|---|---|
| Ramelteon | RAMELTEON 8 mg/1 | Tablet · Oral | Actavis Pharma, Inc. | 00591-2191-00 |
| Ramelteon | RAMELTEON 8 mg/1 | Tablet, Film Coated · Oral | Upsher-Smith Laboratories, LLC | 00832-1250-11 |
| Ramelteon | RAMELTEON 8 mg/1 | Tablet · Oral | Major Pharmaceuticals | 00904-7494-06 |
| Ramelteon | RAMELTEON 8 mg/1 | Tablet · Oral | AvKARE | 42291-0776-30 |
| Ramelteon | RAMELTEON 8 mg/1 | Tablet · Oral | Micro Labs Limited | 42571-0375-01 |
| Ramelteon | RAMELTEON 8 mg/1 | Tablet · Oral | AvPAK | 50268-0822-15 |
| Ramelteon | RAMELTEON 8 mg/1 | Tablet, Film Coated · Oral | Golden State Medical Supply, Inc. | 51407-0523-01 |
| Ramelteon | RAMELTEON 8 mg/1 | Tablet, Film Coated · Oral | TruPharma, LLC | 52817-0235-10 |
| Ramelteon | RAMELTEON 8 mg/1 | Tablet, Film Coated · Oral | Aurobindo Pharma Limited | 59651-0505-01 |
| Ramelteon | RAMELTEON 8 mg/1 | Tablet · Oral | American Health Packaging | 60687-0692-65 |
| Ramelteon | RAMELTEON 8 mg/1 | Tablet · Oral | Bryant Ranch Prepack | 63629-8531-01 |
| Ramelteon | RAMELTEON 8 mg/1 | Tablet | Granules Pharmaceuticals Inc. | 70010-0028-01 |
Therapeutic equivalents & pricing 30 productsclick to expand
Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.
| Product | Manufacturer | Package | NADAC $/unit | AB rating | Availability |
|---|---|---|---|---|---|
| Ramelteon 8 mg | AvPAK | 50 tablets | $0.657 | AB | Discontinued |
| Ramelteon 8 mg | Actavis | 100 tablets | $0.660 | AB | Availability likely |
| Ramelteon 8 mg | Upsher-Smith | 100 tablets | $0.660 | AB | Availability likely |
| Ramelteon 8 mg | Major | 50 tablets | $0.660 | AB | Availability likely |
| Ramelteon 8 mg | Micro | 100 tablets | $0.660 | AB | Availability likely |
| Ramelteon 8 mg | TruPharma, | 100 tablets | $0.660 | AB | Availability likely |
| Ramelteon 8 mg | Aurobindo | 100 tablets | $0.660 | AB | Availability likely |
| Ramelteon 8 mg | American | 50 tablets | $0.660 | AB | Availability likely |
| Ramelteon 8 mg | Xiromed, | 500 tablets | $0.660 | AB | Availability likely |
| Ramelteon 8 mg | Zydus | 100 tablets | $0.660 | AB | Availability likely |
| Ramelteon 8 mg | Dr.Reddys | 100 tablets | $0.667 | AB | Discontinued |
| Rozerem 8 mg | Takeda | 30 tablets | $12.417 | AB | Availability likely |
| Rozerem 8 mg | Takeda | 100 tablets | $12.417 | AB | Availability likely |
| Ramelteon 8 mg | AvKARE | 30 tablets | — | — | FDA listed |
| Ramelteon 8 mg | AvPAK | 50 tablets | — | AB | FDA listed |
| Ramelteon 8 mg | Golden | 100 tablets | — | AB | FDA listed |
| Ramelteon 8 mg | Bryant | 30 tablets | — | — | FDA listed |
| ramelteon 8 mg | Granules | 100 tablets | — | — | FDA listed |
| Ramelteon 8 mg | REMEDYREPACK | 30 tablets | — | AB | FDA listed |
| Ramelteon 8 mg | Zydus | 100 tablets | — | AB | FDA listed |
| Ramelteon 8 mg | Proficient | 100 tablets | — | — | FDA listed |
| Ramelteon 8 mg | Bryant | 30 tablets | — | AB | FDA listed |
| Ramelteon 8 mg | Bryant | 30 tablets | — | AB | FDA listed |
| Ramelteon 8 mg | Bryant | 30 tablets | — | AB | FDA listed |
| Ramelteon 8 mg | Bryant | 30 tablets | — | AB | FDA listed |
| Ramelteon 8 mg | Bryant | 30 tablets | — | AB | FDA listed |
| Ramelteon 8 mg | Bryant | 30 tablets | — | AB | FDA listed |
| Ramelteon 8 mg | Bryant | 30 tablets | — | AB | FDA listed |
| Ramelteon 8 mg | Bryant | 30 tablets | — | AB | FDA listed |
| Ramelteon 8 mg | Bryant | 100 tablets | — | AB | FDA listed |
Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.
Other drugs in the same treatment class
These are different medicines — not other versions of Ramelteon Tablet — that fall in the same broad treatment class (hypnotics, melatonin mt1/mt2 receptor agonists) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.
Identity & classification
Where does this data come from?
Other psychiatry shortages
Ramelteon Tablet shortage FAQs
Is Ramelteon Tablet in shortage?
Which products are affected?
When will Ramelteon Tablet be available again?
Can I still get Ramelteon somewhere?
What should I do if I take Ramelteon Tablet?
Still have a question about the Ramelteon Tablet shortage?
Ask a pharmacist about this shortage →View Ramelteon Tablet on the FDA drug-shortage database →
Where does this data come from?
/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.