OHSU Sleep Disorders Program Studies Long-Term Treatment for Chronic Insomnia

05/15/03    Portland, Ore.

Researchers at Oregon Health & Science University are participating in a clinical trial of the first insomnia drug specifically designed for long-term use. The multicenter, national clinical trial will test the safety and effectiveness of the experimental drug dubbed TAK375.

"Insomnia, like pain, may be symptomatic of a number of underlying diseases or conditions which need to be treated," said Robert Sack, M.D., medical director of OHSU's Sleep Disorders Medicine Program and a professor of psychiatry in the OHSU School of Medicine. "However, patients with chronic insomnia -- insomnia unrelated to any other condition -- require treatment over a longer period of time. TAK375 is intended for these patients."

Approximately 600 people nationwide will participate in this study -- sponsored by Takeda Pharmaceuticals -- including about 20 at OHSU. Participants will take the study drug once a day for a year. All participants will receive the study drug for all but two days, when they will receive a placebo. EKGs and monthly checkups will be provided. The study drug has proved to be effective in preliminary clinical trials; the OHSU study (IRB 7625) will be monitoring long-term safety.

In addition to participating in this drug trial, OHSU's Sleep Disorders Medicine Program recently acquired a state-of-the-art tool, called an actigraph, to help evaluate and treat sleep disorders, such as insomnia. Resembling a wristwatch, this device records patients' sleep patterns in the comfort of their own homes. Traditionally, evaluating patients with sleep disorders required an overnight stay in the hospital. Falling asleep in a strange environment is challenging for patients, making it difficult for physicians to obtain an accurate depiction of their sleep habits. Using the actigraph, patients are able to go about their normal nightly routines and sleep in their own beds, enabling physicians to obtain an assessment of their sleep habits that is true-to-life, and allowing patients to avoid a more costly hospital stay.