![]() However, the macrolide antibiotic clarithromycin has been shown to have GABA-modulating properties, resulting in the development of insomnia or mania in a subset of patients. Currently, there are no hypersomnia therapies that are GABA-antagonists. The investigators hypothesize that pathology in the GABA neurotransmitter system, the brain's major inhibitory system, underlies these central hypersomnias. In addition to side effects including high abuse potential, tachycardia, and altered mental status, treatments are often ineffective and substantial residual sleepiness frequently persists despite poly-therapy. Treatments include traditional psychostimulants (e.g., amphetamine derivatives) as well as wake-promoting agents with unknown mechanisms of action such as modafinil and sodium oxybate. Currently, IH is treated using therapies approved for narcolepsy, despite a lack of clinical trial data and a consensus that treatment response is poor (2). Despite these health, safety, and quality of life consequences, there are no FDA-approved therapies for several forms of central hypersomnia, including idiopathic hypersomnia (IH). They preferentially affect young adults, may result in loss of employment, and can lead to motor vehicle accidents (1). Hypersomnia Idiopathic Hypersomnia Narcolepsyĭrug: Clarithromycin followed by placebo Drug: Placebo then ClarithromycinĬentral hypersomnias are characterized by severe excessive daytime sleepiness despite long sleep periods (>10 hours/night) and the absence of nocturnal sleep pathology. If this study shows that clarithromycin is more effective than placebo in the treatment of hypersomnia, it will identify a potential new therapy for this difficult-to-treat disorder. All subjects will receive both clarithromycin and the placebo at different times, and their reaction times and symptoms will be compared on these two treatments to determine if one is superior. To determine whether clarithromycin is truly beneficial for central hypersomnia, this study will compare clarithromycin to an inactive pill (the placebo). The investigators have treated a few patients with clarithromycin and most have felt that their hypersomnia symptoms improved with this treatment. In a test tube model of this disease, clarithromycin does in fact return the function of the GABA system to normal. They are usually treated with medications approved for narcolepsy, but sleep experts agree that these medications are often not effective for this group of patients.īased on our understanding of the GABA abnormality in these patients, we evaluated whether clarithromycin (an antibiotic approved by the FDA for the treatment of infections) would reverse the GABA abnormality. However, for the remainder of patients, there are no treatments approved by the FDA. For the fraction of cases with narcolepsy, there are FDA-approved, available treatments. In essence, it is as though these patients are chronically medicated with Valium (or Xanax or alcohol, all substances that act through the GABA system), even though they do not take these medications.Ĭurrent treatment of central hypersomnias is limited. In a subset of our hypersomnia patients, there is a naturally-occurring substance that causes the GABA receptor to be hyperactive. However, our group has recently identified a problem with the major brain chemical responsible for sedation, known as GABA. The causes of most of these central hypersomnias are not known. These cases of hypersomnia are presumed to be a symptom of brain dysfunction, and so are referred to as hypersomnias of central (i.e., brain) origin. In other cases, however, hypersomnia occurs even when nighttime sleep is of good quality. Sometimes, hypersomnia is caused by a problem with the quality of sleep occurring at night, for instance when nighttime sleep is disrupted by frequent breathing pauses. The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness and sleeping long periods of time (more than 10 hours per night). Why Should I Register and Submit Results?.
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