Behavioral Therapy Effective in Treatment of Insomnia

Treatment of Insomnia

New clinical data show that changing a person’s attitudes about sleep and teaching new habits is a promising treatment for insomnia and may be an alternative to medication for the treatment of persistent primary insomnia, a sleep disorder that affects up to 5 percent of Americans.

More than one-third of the adult population is bothered by insomnia at least some of the time and 10 percent to 15 percent have chronic, unrelenting insomnia, according to Jack D. Edinger, lead author of the study appearing in the April 11 issue of the Journal of the American Medical Association. Edinger is a medical psychologist with Duke University Medical Center and the Durham VA Medical Center.

“This study shows quite clearly that a cognitive behavioral insomnia therapy can be effective for people who have difficulty staying asleep at night,” Edinger said.

“Many patients were able to reach fairly normal levels of sleep with this treatment and without the use of sleeping pills, and the results lasted through six months of follow-up.”

In terms of this study, cognitive behavioral therapy (CBT) is a treatment that combines changing an individual’s beliefs and attitudes about sleep and then teaching that person how to implement new behavioral patterns or habits in order to improve sleep. For example, people are taught how to think about their sleep in a more constructive way (change of attitude) and also how to establish better sleep patterns by incorporating new habits such as getting out of bed at the same time each day (even if it means getting less sleep) and eliminating daytime napping.

The study also showed that the treatment leads to clinically significant sleep improvements within six weeks, Edinger noted.

CBT appears to be a promising, more universally effective treatment for insomnia, according to Edinger. Early results suggest CBT effectively addresses both sleep-onset and sleep-maintenance problems, and produces a better longterm outcome than do medication or placebo.

The study included 75 study participants with chronic primary sleep insomnia who were divided into three groups. Each group received either cognitive behavioral therapy, relaxation training or placebo therapy for six weeks. Those receiving cognitive therapy saw a 54 percent reduction in their wake time after sleep onset as compared to a 16 percent reduction for the group receiving relaxation therapy and 12 percent for the placebo group.

Currently, sedative hypnotics or antidepressants are often used for treating insomnia, but many experts feel that neither should be recommended for longterm treatment of chronic primary insomnia.

The study was funded by the National Institute of Mental Health and is one of the only studies done to date in the area of behavioral insomnia research that has used a double-blind, placebo control group design.

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Intra-Cellular Initiates Clinical Trial For Sleep Maintenance Insomnia

Intra-Cellular Therapies has initiated a sleep maintenance insomnia (SMI) Phase 2 clinical study using its drug candidate ITI-722. ITI-722 acts predominantly as a selective 5-HT2A receptor antagonist and represents an important new approach to the treatment of SMI. Because of its novel separation of 5-HT2A and dopamine receptor modulatory activities, ITI believes, ITI-722 can be used not only to treat SMI but it may be highly appropriate for the treatment of sleep disorders that accompany neurodegenerative disorders, including Parkinson’s disease and other psychiatric disorders.

“The progression of ITI-722 into Phase 2 for SMI represents the advancement of this important new class of therapeutics,” stated Sharon Mates, Ph.D., Chairman and Chief Executive Officer of Intra-Cellular Therapies. “This drug candidate has therapeutic potential to treat SMI in the general population, and in other patient populations who have been underserved, particularly peri- and post-menopausal women, and in other disorders where insomnia is a problem, including osteoarthritis, depression, Parkinson’s disease and other neurologic and psychiatric disorders.”

The Phase 2 program is a multi-center, randomized, double-blind placebo- controlled study in patients with SMI. The primary endpoint is an assessment of objective slow wave sleep using polysomnography (PSG). Secondary endpoints include other objective and subjective measures of SMI and sleep efficiency. Additionally, the study will make an assessment regarding next-day cognitive performance.

ITI-722 is a low-dose formulation of ITI-007, ITI’s first-in-class 5-HT2A antagonist/ dopamine receptor protein phosphorylation modulator (DPPM), presently in clinical trials for the treatment of schizophrenia.

About Sleep Maintenance Disorders

From nightmares to insomnia to sleep apnea, sleep disorders disrupt the sleep of millions of people all over the world. In particular, about 20% to 30% of the U.S. population complains of waking too early several times a week, a symptom of sleep maintenance insomnia (SMI) that is characterized by symptoms that include waking up frequently during the night with difficulty returning to sleep, waking up at early hours, and unrefreshing sleep. The majority of sleep complaints are related to SMI rather than sleep initiation or difficulty in falling asleep. However, there are no drugs currently approved in the U.S. that address only SMI. Furthermore, current sleep medications typically induce sedation and result in significant increases in daytime sleepiness that impairs quality of life in these patients. There is, therefore, a significant need for sleep medications that improve sleep quality without next-day hangover effects.

ABOUT ITI-722

ITI-722 is a highly potent 5HT2A antagonist for the treatment of sleep maintenance insomnia. Preclinical data has shown that ITI-722 is not sedating and should not exhibit next-day hangover effects that are commonly associated with other sleep medications. ITI-722 is expected to have a strong safety profile with no addiction liability. This compound is being evaluated for the treatment of sleep disorders in various patient populations with sleep maintenance problems and in other sleep disorders where staying asleep affects the quality of life, including nocturnal awakenings related to osteoarthritic pain, hot flashes in post-menopausal women and many psychiatric and neurodegenerative diseases.