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Novel Pill Helps Older People With Insomnia
May 6, 2004 (New York City) -- A new medication can help the millions of elderly people who toss and turn all night long to sleep more soundly, new research shows.
In a study of more than 250 older people with insomnia, the new sleeping pill, called Estorra, significantly reduced the amount of time they lie awake in bed, reports W. Vaughn McCall, MD, professor and chairman of the department of psychiatry and behavioral medicine at Wake Forest University Baptist Medical Center in Winston-Salem, N.C.
The experimental drug, which slows brain metabolism and activity, also helped elderly people with insomnia fall asleep faster and cut down on daytime drowsiness, he says.
But the big benefit is its ability to prevent people from waking up once they have gone to bed, McCall tells WebMD.
"Young people have more trouble falling asleep but once asleep, will stay asleep," he explains. "But as you get older, there's a tendency to have more and more trouble with nighttime awakenings."
That's where Estorra, which McCall predicts could be on the market by early fall, comes in. Estorra's maker, Sepracor Inc., funded the study.
Less Tossing and Turning
Speaking here Thursday at the annual meeting of the American Psychiatric Association, McCall says that the drug shaved about 40 miserable minutes off the amount of time that elderly people with insomnia spent tossing and turning at night.
For the study, the researchers randomly assigned 265 people with insomnia, aged 65 to 85, to either Estorra or a placebo. At the start of the study, studies in a sleep lab showed patients lie awake an average of over 1.5 hours each night.
By two weeks later, those who were taking Estorra were tossing and turning an average of only one hour, compared with 73 minutes for those on placebo, McCall says.
There were other benefits too. Before the study began, it took about 45 minutes for the patients to fall asleep. Two weeks later, those given Estorra were dozing off in an average of 15 minutes, compared with a half hour for those taking the placebo, he says. Patients on Estorra also napped less and were more alert during the day.
Though McCall explains an equal number of patients in both groups suffered side effects such as headaches he says Estorra is "quite safe."
Insomnia Affects Attention, Memory
More than half of older Americans have at least one complaint about how well they can sleep. The ramifications are troubling: There can be problems with attention, memory, performance, and even a negative impact on overall quality of life.
In the study, though, patients who took Estorra showed improved quality of life on standardized tests, McCall says. "That's really important."
Currently, the FDA only allows most sleeping pills, such as Valium, to be prescribed for two weeks at a time. That's because after that, the patient builds up a tolerance and the drug works no better than placebo, he says.
But McCall says there's a chance that Estorra, which is taken 30 minutes before bedtime, may eventually be prescribed for longer periods. The reason: Another study showed that the drug continued to work better than placebo even after six months, he says.
"It's a major advance for the elderly," McCall says.
Thomas Roth, PhD, director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, agrees.
"Estorra is effective for the elderly population," says Roth, who was not involved in the study but has studied the drug in younger persons. "Elderly people have difficulty maintaining sleep and this drug appears to help. It not only puts you to sleep, but keeps you asleep."
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