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The circadian sleep–wake cycle is mediated by endogenous melatonin from the pineal gland. Although the melatonin-receptor agonist ramelteon (Rozerem) is FDA approved for use in patients with chronic insomnia, the drug’s efficacy for that indication appears to be modest (JW Nov 9 2006). In two manufacturer-funded trials, researchers evaluated whether a newer melatonin-receptor agonist — tasimelteon, which is not yet FDA-approved — is useful for coping with acute changes in sleep cycle, as in jet lag or shift work.
In one randomized trial, researchers abruptly advanced the bedtimes of 39 volunteers in a sleep lab by 5 hours (from 11 pm to 6 pm) and assigned them to receive one of four doses of tasimelteon or placebo 30 minutes before bedtime f…