Friday, January 31, 2014

FDA Okays Hetlioz (Tasimelteon) for Sleep Disorder in Blind

The US Food and Drug Administration (FDA) has approvedtasimelteon ( Hetlioz, Vanda Pharmaceuticals Inc) for the treatment of non–24-hour sleep-wake disorder (non-24), the first such drug approved for this condition, the agency announced today.
Non-24 is a chronic circadian rhythm disorder that disrupts the sleep-wake cycle and affects the majority of totally blind individuals. Without input from the eyes, information about environmental light levels fails to reach the suprachiasmatic nuclei in the hypothalamus to synchronize the internal clock.
As a result, levels of the hormone melatonin, produced by the pineal gland and playing a key role as a feedback regulator of the master circadian clock, peak at later and later times each day, disrupting the sleep-wake cycle.

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