First OTC Approval! 'Rozerem® S', a Sleep Improvement Drug Containing Medical Ingredient 'Ramelteon', Receives Manufacturing and Marketing Approval

Alinamin Pharmaceutical Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo) announced that it received manufacturing and marketing approval on Wednesday, May 20, for its sleep improvement drug 'Rozerem® S' (a guidance-required drug), which is the first OTC medication to contain the same active ingredient (ramelteon) as the prescription version. Wanting to sleep but unable to do so is often caused by a 'disturbed internal clock.' The internal clock is a biological system that regulates various physiological rhythms in the body, ticking in an approximate 24-hour cycle. The rhythm of sleep and wakefulness is adjusted by this clock, keeping a natural cycle of waking in the morning and feeling sleepy at night, but this can be disrupted by lifestyle habits, the environment, and stress. 'Rozerem® S' works on the internal clock that governs the balance between sleep and wakefulness. It acts similarly to melatonin, the so-called 'sleep hormone,' to shift the body towards sleep and guide it into natural slumber. Taking one tablet once a day within 30 minutes before bedtime effectively relieves temporary difficulty in falling asleep. 'Ramelteon' contained in 'Rozerem® S' was developed as a prescription drug by Takeda Pharmaceutical Company Limited, the predecessor of our company, and has been prescribed to many patients since its launch in 2010. Because 'Rozerem® S' is a switch-OTC drug, it is classified as a guidance-required drug that requires an explanation from a pharmacist at the time of sale. We have been preparing for the launch of this product so that customers suffering from temporary insomnia can access it through drugstores and pharmacies nationwide. Under our corporate message of 'Changing Tomorrow's Vitality,' we will continue to strive to contribute to the vibrant daily lives of a wide range of customers by providing high-quality and excellent products, including this one. 1. Product Name: 'Rozerem® S' (Guidance-Required Drug) 2. Scheduled Launch Date: Tuesday, July 28, 2026 3. Indication: Relief of the following symptoms of temporary insomnia: difficulty falling asleep. 4. Dosage and Administration: Take the following amount once a day with water or warm water without chewing, within 30 minutes before bedtime. - Ages 15 and over: 1 tablet, once a day. - Under 15: Do not take. 5. Features: Regulates the internal clock to guide natural sleep; once-daily dose; small, approximately 7mm diameter film-coated tablet. 6. Active Ingredient: 8mg of Ramelteon per tablet. 7. Customer Inquiries: Alinamin Pharmaceutical Co., Ltd. Customer Consultation Office: 0120-567-087 (9:00 - 17:00, excluding weekends and holidays).