Main useUsed to improve difficulty falling asleep in insomnia.A brief overview of Japanese approved uses. Check the PMDA label below for product-specific conditions.
- Japan product name
- ロゼレム錠8mg
- Brand
- Rozerem
- Generic name
- Ramelteon
- Japanese generic name
- ラメルテオン
- Chinese name
- 雷美替胺
- Marketing authorization holder
- 武田薬品工業株式会社
- Strengths
- 8 mg
- Dosage form
- tablet
- Therapeutic area
- Neurology
- Regulatory status
- Medical
- Label updated
- 2026-09-01
- TOKYO MEDI verified
- 2026-09-22
Regulatory status note
Prescription-only designation removed in September 2026; still listed by PMDA as a medical-use medicine.
Official source
These links go directly to PMDA records for this Japanese product. Professional and patient-facing sources are separated.