FDA Approves First Noncontrolled Prescription Medication for Insomnia

The FDA has approved a new prescription sleep aid called Rozerem, which will reportedly treat insomnia without causing dependence.  The drug is manufactured by Takeda Pharmaceuticals, based in Lincolnshire, Illinois, a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd., Japan’s largest pharmaceutical company.

The new drug, which will be available by late August, works differently from other sleep aids by helping to regulate the body’s sleep-wake cycle. This will provide a new option for relief to the one-third of American adults who suffer from insomnia to one degree or another.

Rozerem works by stimulating the melatonin receptors in the brain, which regulate the sleep-wake cycle.  It is this cycle that keeps you alert during the day and in the evening allows the body to wind down and fall asleep at night.
"In people who sleep normally, the pineal gland in the brain responds to darkness by producing a hormone called melatonin," says psychiatrist Louis J. Mini, MD, Takeda North America’s medical director for neuroscience. "This natural melatonin … dampens the alerting signal so the sleep load overrides [the waking drive] and allows a person to fall asleep." Insomnia occurs when these drives get out of balance.

Whereas many sleeping pills address the problem by trying to enhance the sleep drive, Rozerem it seems tries to suppress the wake drive by simulating the effect of melatonin. Rozerem, Mini claims, is more effective that melatonin supplements, for which there no clinical trials yet.

In addition, Rozerem, unlike the sleeping pills Ambien, Lunesta, and Sonata, is completely non-addicting and is the first prescription sleep aid that is not a controlled substance.

According to a news release by the drug’s manufacturer Takeda Pharmaceuticals North America, the 8-milligram tablets show no evidence of abuse and can safely be prescribed for long term use.

 Some doctors believe that because Rozerem is not habit forming, it will be a popular alternative to other sleeps aids and will encourage those afflicted with insomnia to treat the condition with medication.

David Neubauer, MD, associate director of the Johns Hopkins Sleep Disorders Center and author of Understanding Sleeplessness: Perspectives on Insomnia, said: "There will be a lot of interest. One, because it is the first sleep drug in a very long time to have a new mechanism of action. And two, I think there is going to be a very high comfort level in prescribing this drug. The safety level is extremely positive. A lot of doctors — and a lot of patients who haven’t been interested in a sleeping pill — may view this in a different light and may be more comfortable giving it a try."

Others, however, such as Dr. Milton Kramer, who is director of the sleep disorders center of Bethesda Hospital in Cincinnati and teaches psychiatry at the University of Cincinnati and at Wright State University School of Medicine in Dayton, Ohio, do not believe the impact of the drug will be that substantial, stating “its effectiveness in chronic [sleeping-pill] users is not enormous.”

While Rozerem will likely be seen as safe alternative for insomnia relief it does have several side effects including somnolence, dizziness, and fatigue. It is intended for people who have difficulty falling asleep and should not be used by people who have severe liver problems, since the drug is metabolized by the liver. 

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