Takeda Pharmaceutical Co. has received FDA approval to market ramelteon (Rozerem), a new sleeping pill that is indicated for long-term treatment of adults with insomnia that is marked by difficulty falling asleep. Ramelteon 8 mg tablets have a unique therapeutic mechanism that selectively targets two receptors in the brain's suprachiasmatic nucleus.
According to Takeda, ramelteon induced a state similar to natural sleep. The new medication is the only prescription sleep aid that has not been designated a scheduled drug. Ramelteon has been shown to carry no risks of abuse, withdrawal, or dependency, and is negligible for next-day "hangover" effects.