With Food and Drug Administration approval of ramelteon 8-mg tablets for short-term and long-term treatment of insomnia in adults, US physicians have for the first time a prescription option with no evidence of abuse or dependence.

Because of the lack of any evidence suggesting abuse potential, the drug has not been designated as a controlled substance by the U.S. Drug Enforcement Administration (DEA). All other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the DEA.

In addition, the drug is the first prescription insomnia medication to have a new therapeutic mechanism of action in 35 years.

"People with insomnia are not only affected by their sleeplessness at night; insomnia's impact is also in how they feel and function the next day," said Thomas Roth, PhD, director of the Sleep Disorders and Research Center, Detroit, Mich. "Current therapies often used for insomnia work by broadly inhibiting the activity of neurons in the brain. Ramelteon treats insomnia by specifically affecting the activity of neurons in an area of the brain involved in the sleep-wake process, and has been shown to carry no risks of abuse, withdrawal, or dependency, and negligible risk for next-day 'hangover' effects."

"ROZEREM (ramelteon) represents an exciting new option in sleep medicine that we anticipate can help millions of people who live with sleepless nights and sluggish days," said Yasuchika Hasegawa, president and chief operating officer of Takeda. "The approval marks a major milestone for Takeda as we seek to bring innovative therapies to patients in a variety of therapeutic areas."

Ramelteon has a unique therapeutic mechanism of action that selectively targets two receptors located in the brain's suprachiasmatic nucleus. This region is known as the body's "master clock" because it regulates 24-hour, or circadian, rhythms including the sleep-wake cycle.

Based on recently presented clinical trials, ramelteon has been shown to be safe for older adults, as well as those who have mild-to-moderate chronic obstructive pulmonary disease and mild-to-moderate sleep apnea.

Ramelteon should not be used by patients with severe hepatic impairment or in combination with fluvoxamine.