According to the National Center for Sleep Disorders Research at the National Institutes of Health, about 30% to 40% of adults say they have symptoms of insomnia within a given year, and about 10% to 15% of adults say they have chronic insomnia. These patients have tried everything from yoga and hypnosis to natural remedies like melatonin to prescription drugs such as Ambien and Lunesta. Now—and since its launch just over one year ago—insomnia sufferers are also trying Rozerem, the first non-controlled prescription medication for insomnia in adults. But what makes it different, and how is the new drug doing?

“All other prescrition insomnia medications work on GABA receptors in the brain. They act on these receptors to produce sleep,” said Louis Mini, MD and medical director of neuroscience at Takeda Pharmaceuticals North America Inc. “Rozerem is the first prescription insomnia medication that works differently.”

Unlike other drugs, Rozerem works on specific receptors in a part of the brain known as the SCN, or the “clock,” as Mini calls it. Rozerem targets two receptors—MT1 and MT2 —and binds to these receptors, which are linked to melatonin. As Mini explains it, in normal sleepers, as the day wears on, a sleep debt or sleep loan builds up. By 9pm or after, normal sleepers produce melatonin which aids in the sleep process. While Rozerem does not produce melatonin, it “acts on melatonin in a potent and specific part of the brain, specifically the SCN,” said Mini. This process, in turn, triggers sleep.

The beauty of Rozerem is that the drug does not appear to have effects that indicate potential for abuse or motor or cognitive impairment. A recent study by The Johns Hopkins School of Medicine—as reported in last week’s issue of Sleep Report—indicates as such. Indeed, for patients with a potential for abuse and deeper dependency, Rozerem could make a significant impact. “There is a population that will be very interested in Rozerem,” said Mini. “Especially anyone with a fear of addiction.”

Moreover, Rozerem is regulated by the FDA, unlike the natural supplement of melatonin. “Melatonin is just a supplement that is not a prescription and not regulated in any specific manner or FDA approved. For example, it’s purity and dosage are not regulated,” said Mini. “Both recent studies and the NIH have reached a consensus that melatonin alone has limited if any clear effectiveness on insomnia.”

Time—and feedback from health care consumers—will tell us just how well Rozerem is doing. For now, the makers of Rozerem, Takeda Pharmaceuticals North America, remain quite hopeful. “It’s a real breakthrough because it’s a non-controlled substance and a new mechanism of action,” said Mini.

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