Study: Novel Drug Safely Treats Insomnia
Indiplon Turns Off Overactive Brains, Helping People Fall Asleep
May 5, 2004 (New York City) -- A novel sleeping pill that slows down overactive brains can help insomniacs to get a better night's rest, a new study suggests.
In the study of nearly 200 men and women who had trouble going to bed at night, those treated with the new drug, known as Indiplon, fell asleep faster compared with those who got a dummy pill.
Insomniacs treated with Indiplon also reported getting a more refreshing rest, says Jim Walsh, PhD, executive director and senior scientist at the Sleep Medicine and Research Center at St. Luke's Hospital in St. Louis.
Importantly, the drug did not cause morning drowsiness -- a problem commonly associated with sleeping pills, he tells WebMD.
According to the National Institutes of Health, more than 70 million Americans experience insomnia at some point in their lives. And about 13% of women and 9% of men suffer chronic insomnia that persists for more than five years.
Keeps Brain on Even Keel
Presenting at the annual meeting of the American Psychiatric Association (APA), Walsh says Indiplon is a new type of drug known as a GABA-A modulator.
GABA is a brain chemical that slows brain activity, promoting relaxation and sleep. However, if there's not enough GABA available, brain activity increases. That's what happens in people with insomnia, he explains. By making the body's own GABA work more efficiently, Indiplon keeps the brain on a more even keel, helping patients to relax and fall asleep.
Philip R. Muskin, MD, professor of clinical psychiatry at Columbia University in New York and chairman of the APA scientific program committee, says sleep experts are excited about new agents like Indiplon that can turn off the brain without causing a sense of euphoria, a feeling that often encourages dependence on other sleep medications like Valium.
"We're looking for substances that can act on GABA, a brain chemical that is impaired in sleep, anxiety, and even seizures," he tells WebMD. "Drugs such as [Valium] can help people to sleep but they cause a sense of euphoria and thus are potentially addictive."
An added plus, Muskin says, is that the GABA-A modulators "don't make you feel sleepy the next day."
A Better Night's Rest
Walsh says they studied 194 people who were "severely sleep impaired," tossing and turning for at least a half-hour or so before falling asleep each night for at least three months. The patients were given either placebo or one of two doses of Indiplon.
One day later, those who got either dose of Indiplon fell asleep in 27 minutes, compared with 37 minutes for those on placebo.
A month later, those being treated with the higher dose of drug were dosing off in just 25 minutes, while those in the placebo group had worsened -- they now tossed and turned for an average of 40 minutes.
The volunteers who took Indiplon also reported that they got a better night's rest than those on placebo, Walsh says.
Importantly, the drug was associated with no signs of drowsiness, he says, with three-fourths of patients in all three groups "awake and alert" the next day.
"This is a very safe drug," he tells WebMD. "By the time you wake up the next morning, it's completely out of the body, or at trivial levels."