Thursday, August 11, 2005

CNS Update: Sleep Medicine

Michael Rack, MD, (blog: sleepdoctor) scooped me on this one: ramelteon (formerly named TAK-375, now called Rozerem® - Takeda Pharmaceuticals North America) was recently approvedFuture Headquarters Campus for Takeda Pharmaceuticals by the USA FDA for treatment of insomnia.  Check his post for details.  Basically, it acts on melatonin MT1 receptors, so it should be nonaddictive and should be extremely safe in overdose.  That latter point is of great interest to psychiatrists.  

Melatonin is a popular "natural" substance used to treat insomnia.  Success is highly variable.  It helps some people, but it seems that most people get no benefit.  There is no FDA quality control for nutritional supplements, so some OTC versions of "melatonin" actually contain no active ingredient.  That is one reason why traditional MD's tend to be skeptical of such products.  Plus, there was a small case series of patients with bipolar disorder who did not improve when treated with melatonin; one developed a free-running (unentrained) sleep-wake cycle after melatonin withdrawal.  I hope Takeda is watchful for this kind of thing in their post-marketing surveillance; it's the kind of thing that is unlikely to show up in phase I-III studies, but may show up when a larger, more heterogeneous population is exposed.

Practical matters aside, it is time to move on the the fun part: pure, preclinical, science, with no obvious practical application.  In this post, I ramble on about some basic science related to sleep disorder research, that may someday enlighten us about an important subsystem in the brain.  Continue reading here.

Categories: science, sleep disorders, neurochemistry
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