Melatonin is a neurohormone produced in the pineal gland that is involved in the regulation of circa-dian rhythm function. It works through activation of its intrinsic receptors found in the supraehiasmatic nucleus (SCN) within the hypothalamus. Melatonin synthesis is under direct neural control from SCN firing. The sleep/wake cycle is a circadian rhythm controlled by this neural complex. Problems in the functioning of this system can therefore lead to sleep disorders. While melatonin itself has been shown to be effective in the treatment of sleep disorders, problems due to its ubiquitous action in the brain have limited its use for this indication, TAK-375 is a potent melatonin receptor agonist, specific for the ML_1 receptor subtype known to be intricately involved in circadian rhythm function. TAK-375 has been heralded as an exciting new drug candidate for the treatment of patients with insomnia and circadian rhythm dysfunction. Phase III trials are currently under way to test the drug's viability for use in patients with sleep disorders.
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