Ramelteon
Tablet · trading as Rozerem
To Be Discontinued Active (discontinuing) — Day 56
High impact — Sole-source drug with no supply currently available from this manufacturer.
FDA shortage record
- Substance
- Ramelteon
- Brand name
- Rozerem
- Manufacturers / suppliers
-
- Takeda Pharmaceuticals America, Inc.
- Takeda Pharmaceuticals USA Inc.
- Dosage form
- Tablet
- Presentation
- Rozerem, Tablet, 8 mg (NDC 64764-805-10)
- Route(s)
- ORAL
- Therapeutic category
- Psychiatry
- Package NDC
64764-805-10- Initially posted
- 03/19/2026
- Days on shortage list
- 56
- Discontinued
- 03/19/2026
- Current FDA status
- To Be Discontinued
- Shortage entries (current dataset)
- 1 record for Ramelteon
Reason and context
Product is expected to be available through February 2027.
Manufacturer contact
Per the FDA record, the manufacturer's contact for supply inquiries is 877-825-3327.
If you're affected by this shortage
- Talk to your prescribing clinician or pharmacist about therapeutic alternatives. Do not switch medications on your own.
- Ask your pharmacy to check supply across multiple wholesalers and other branches.
- Check current pharmacy pricing and availability via GoodRx (affiliate link).
- Report a continuing supply problem to FDA via the FDA Drug Shortages contact form.
Sources
- FDA Drug Shortages database, accessed via the openFDA Drug Shortages API.
- FDA Structured Product Label (SPL set ID
9de82310-70e8-47b9-b1fc-6c6848b99455). - FDA UNII identifier:
901AS54I69. - See the Drug Shortage Tracker methodology for sourcing, update cadence, normalization rules, and limits.
Important
This page reproduces publicly available FDA shortage data for informational purposes only. It is not medical advice and does not establish a clinician-patient relationship. Shortage status changes frequently; verify directly with your pharmacist or the FDA Drug Shortages site before making any treatment decision.