Ramelteon 8 mg Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 8 mg
Reference Brands: Rozerem (USA)
Category: Sleep Disorders
Ramelteon is a Sleep Disorders product available as Tablets in strengths 8 mg. It corresponds to the reference brand Rozerem (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.
Product Description:
Ramelteon is a melatonin receptor agonist used for the treatment of insomnia, specifically in adults who experience difficulty with sleep onset. It is marketed under the brand name Rozerem and acts by selectively binding to MT1 and MT2 melatonin receptors in the suprachiasmatic nucleus of the brain, the region responsible for regulating the sleep–wake cycle. By mimicking the natural action of endogenous melatonin, ramelteon helps promote the initiation of sleep without exerting sedative, anxiolytic, or muscle-relaxant effects.
Clinical studies have demonstrated that ramelteon significantly reduces latency to persistent sleep, meaning it shortens the time required to fall asleep. In controlled trials, an 8 mg dose showed a measurable reduction in sleep onset time compared to placebo, with consistent effects observed during early treatment. Meta-analyses of longer-term use indicate modest improvements in subjective sleep latency, sleep quality, and sleep efficiency, although effects on total sleep time are variable.
Ramelteon is approved for long-term use and is considered distinct from benzodiazepines and non-benzodiazepine hypnotics, as it does not cause dependence, tolerance, or rebound insomnia. Its favorable safety profile makes it a suitab
Ramelteon — third party manufacturing & bulk supply
Ramelteon 8 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Ramelteon listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Ramelteon →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Ramelteon is used for the treatment of insomnia in adults, specifically for difficulty in falling asleep (sleep-onset insomnia).
Ramelteon is a synthetically produced melatonin receptor agonist designed to mimic the action of endogenous melatonin on MT1 and MT2 receptors.
The trade name of Ramelteon is Rozerem.
Rozerem was originally developed and marketed by Takeda Pharmaceutical Company.
The generic name of Ramelteon is ramelteon.
The brand name of Ramelteon is Rozerem.
Ramelteon finished dosage forms are manufactured by different pharmaceutical manufacturers depending on the market, with original branded production associated with Takeda-approved manufacturing facilities.
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