New Insomnia Treatments Found Effective

Both Drugs Have Few to No Side Effects

From the WebMD Archives

June 10, 2003 -- People with insomnia may soon have more options to help them get a good night's sleep. Two new drugs have been found effective in treating insomnia with few or no side effects.

Reports on both insomnia treatments were presented last week at the annual meeting of the Associated Professional Sleep Societies in Chicago.

Insomnia Treatment Without Grogginess

The first treatment, an experimental drug called TAK-375 developed by Takeda Pharmaceuticals North America, was more effective than placebo in inducing sleep and increasing total sleep time in patients with either short-term or long-term insomnia.

Sleep specialist Thomas Roth, MD, who conducted one of the TAK-375 studies presented last week, says the compound offers the promise of promoting sleep without making people feel "drugged" and groggy.

"This has tremendous potential advantages in terms of safety," Roth tells WebMD. "If someone needs to wake up in the middle of the night, they can."

Yearlong Results

A separate presentation at the sleep meeting addressed the effectiveness of the experimental drug Estorra, developed by Sepracor Inc. of Boston. Nearly 300 patients took the drug every night for a year, and most reported improved sleep as well as improved daytime alertness and functioning.

In a news release issued Monday, researcher Andrew Krystal, MD, of Duke University called the research a "landmark study for the treatment of insomnia."

"The fact that nearly 300 patients took this medication nightly for a year provides an unprecedented wealth of data," he says. "[Estorra] demonstrated sustained therapeutic effect for the full twelve months of this study."

The National Institutes of Health reports that more than 70 million Americans are affected by either short-term or long-term insomnia. Many people are never treated, and many who are treated do not need drug treatments at all, says sleep disorders specialist James Wyatt, PhD. Wyatt tells WebMD that too many people may be taking drugs for insomnia.

"The data are pretty clear that nondrug treatments for chronic insomnia are about as effective for many patients as the drug treatments," Wyatt tells WebMD.

Nondrug insomnia treatments include relaxation techniques, having a bedtime routine, and learning various coping mechanisms.

Revolutionary Treatments?

But Roth says new insomnia drugs could revolutionize the treatment of sleep disorders, in much the same way that SSRIs changed the treatment of depression and Cox-2 inhibitors changed the treatment of rheumatoid arthritis.

"Chronic insomnia occurs in about 10% of the population, and it is associated with tremendous morbidity," Roth says. "It is clear that we need mediations that are safer because this affects so many people."

Show Sources

SOURCES: Associated Professional Sleep Societies annual meeting, Chicago, June 3-8, 2003. Thomas Roth, MD, director, Sleep Center, Henry Ford Hospital, Detroit. James Wyatt, PhD, laboratory director, Sleep Disorders Center, Rush Presbyterian St. Luke's Medical Center, Chicago.
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