Many drugs prescribed for chronic insomnia are not approved for that purposeJune 15, 2005WINSTON-SALEM, N.C. - The most frequently used drugs for treating chronic insomnia have never been approved for that purpose by the U.S. Food and Drug Administration (FDA), according to a sleep expert from Wake Forest University Baptist Medical Center. Vaughn McCall, M.D., M.S., professor and chairman of the Department of Psychiatry and Behavioral Medicine, told a special consensus panel at the National Institutes of Health (NIH) that he could find no evidence that randomized controlled clinical trials had ever been conducted for five of the 10 pharmaceuticals prescribed most often for chronic insomnia. None of the 10 are currently approved for insomnia, though all are FDA-approved as antidepressants, antipsychotics or sedatives, he said. The NIH State-of-the-Science Conference on Manifestations and Management of Chronic Insomnia in Adults, sponsored by the National Institute of Mental Health and Office of Medical Applications Research, will continue through Wednesday, seeking to build consensus on a series of questions on chronic insomnia. "There is widespread use of off-label prescribed medications for insomnia," said McCall, who directs the sleep laboratory at Wake Forest Baptist. But he said that evidence to support their effectiveness is poor. He said that during the 1990s, the use of FDA-approved sleep medications called hypnotics declined by 54 percent between 1987 and 1996, "while the use of trazodone (Desyrel) and other sedating antidepressants rose by 146 percent. This trend continued through 2002, such that trazodone became the most frequently used medication for the treatment of insomnia." He said that 78 percent of psychiatrists now make trazodone their first choice. "In addition to trazodone, a wide variety of antidepressants, antipsychotics and sedatives gained favor for the treatment of insomnia despite the fact that none of these medications are approved for the treatment of insomnia." McCall said the widespread use of these drugs "suggests that there must be substantial evidence supporting this practice." So he searched the medical literature for all 10 drugs, looking for randomized controlled trials, especially those in which the drug being tested was compared to an inert placebo. He said he found one study that showed that trazodone was superior to placebo in the first week of treatment for insomnia, but no better than placebo in the second week. For patients already on antidepressants, he found two small short-term trials that showed use of trazodone was better than placebo. He found a limited number of small studies to support use of four other drugs. "Why are they used so often?" he asked. One possible reason was that many of the approved hypnotic drugs, which are controlled substances, have firm limits on duration of use, forcing psychiatrists to find something else. Secondly, "Erroneous beliefs on the part of providers that off-label medications have demonstrated sustained efficacy and are safer," he said. He told the panel, "Full scale, placebo-controlled clinical trials of some off-label medications are warranted in the treatment of insomnia." Wake Forest University Baptist Medical Center |
|||||||||||||||||||||
| Related Insomnia Current Events and Insomnia News Articles Green tea shows promise as chemoprevention agent for oral cancer, M. D. Anderson study finds Green tea extract has shown promise as cancer prevention agent for oral cancer in patients with a pre-malignant condition known as oral leukoplakia, according to researchers at The University of Texas M. D. Anderson Cancer Center. Fighting Sleep, Penn Researchers Reverse the Cognitive Impairment Caused By Sleep Deprivation A research collaboration led by biologists and neuroscientists at the University of Pennsylvania has found a molecular pathway in the brain that is the cause of cognitive impairment due to sleep deprivation. Exercise reduces fatigue in cancer patients undergoing chemotherapy Supervised exercise programmes that include high and low intense cardiovascular and resistance training can help reduce fatigue in patients with cancer who are undergoing adjuvant chemotherapy or treatment for advanced disease. U-M discovery about biological clocks overturns long-held theory University of Michigan mathematicians and their British colleagues say they have identified the signal that the brain sends to the rest of the body to control biological rhythms, a finding that overturns a long-held theory about our internal clock. Novel, soy-based SE5-OH containing Natural S-equol supplement reduced hot flash frequency by nearly 59 percent SE5-OH containing Natural S-equol, a novel soy germ-based ingredient in a supplement, improved menopausal symptoms, including significantly reducing hot flash frequency by nearly 59 percent, according to a peer-reviewed study in Japanese women. Penn studies point to strategies for reducing painful breast cancer drug side effects Aromatase inhibitors, the same drugs that have buoyed long-term survival rates among breast cancer patients, also carry side effects including joint pain so severe that many patients discontinue these lifesaving medicines. 'Alert status' area in brain discoved by Hebrew University scientists A new understanding of how anesthesia and anesthesia-like states are controlled in the brain opens the door to possible new future treatments of various states of loss of consciousness, such as reversible coma, according to Hebrew University of Jerusalem scientists. Insomnia is bad for the heart Can't sleep at night? A new study published in the journal Sleep has found that people who suffer from insomnia have heightened nighttime blood pressure, which can lead to cardiac problems. Workplace bullying is associated with sleep disturbances A study in the Sept.1 issue of the journal SLEEP shows that current or past exposure to workplace bullying is associated with increased sleep disturbances. Chemotherapy for breast cancer is associated with disruption of sleep-wake rhythm in women A study in the Sept.1 issue of the journal Sleep shows that the sleep-wake activity rhythms of breast cancer patients are impaired during the administration of chemotherapy. More Insomnia Current Events and Insomnia News Articles |
|||||||||||||||||||||
|
|||||||||||||||||||||
|
|||||||||||||||||||||