The Food and Drug Administration has approved Rozerem (ramelteon), the first sleeping pill that can be prescribed for more than a few weeks without risk of addiction. That attribute could make it a better choice for insomniacs, most of whom tend to have chronic sleeplessness, according to Eric Nofzinger, an associate professor of psychiatry and sleep specialist at the University of Pittsburgh School of Medicine. Studies by the drug's maker, Takeda Pharmaceuticals, show that Rozerem is not addictive, does not cause rebound insomnia, and that long-term use does not dull its effects. "We may be able to use this with greater impunity," said Helene Emsellem, director of the Center for Sleep and Wake Disorders in Chevy Chase, who was an investigator in the clinical trials that led to the drug's approval.
Pluses and Minuses Rozerem promotes sleep by acting on two brain receptors for melatonin, a hormone that helps regulate the body's sleep/wake cycle. As with other sleeping pills, people who take Rozerem will be advised not to consume alcohol or operate heavy machinery. Because Rozerem won't produce hangovers or disorientation on waking, it may be a good choice for people over 65, said Nofzinger. Studies suggest, however, that Rozerem may not work as well as in younger patients. People with severe liver damage or who are using the antidepressant Luvox (fluvoxamine) should not take Rozerem.
No Guarantees In studies, Rozerem helped people fall asleep faster than did a placebo. But Nofzinger said it may be less helpful to those who wake up multiple times or very early in the morning. Emsellem said the drug should be used in conjunction with behavioral therapy. When it reaches the market in September, Rozerem is expected to cost about $80 to $100 a month -- roughly the same as other sleep drugs.
-- Alicia Ault