Summary

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• Hetlioz (tasimelteon) is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults, for nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older, and for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age.
• This summary is based on the review of one systematic review(s)/meta-analysis(es). ^[1]
• Tasimelteon significantly improves sleep-related outcomes in patients with sleep disturbances related to ocular disease, including entrainment, midpoint of sleep timing, lower-quartile of night-time sleep, and upper-quartile of daytime sleep, with low-to-moderate quality evidence.
• Melatonin shows effectiveness in causing entrainment, increasing total sleep time, and reducing sleep latency, but the evidence is low quality and studies have a risk of bias.
• Both tasimelteon and melatonin are effective in causing entrainment of circadian rhythms, but tasimelteon demonstrates additional improvements in specific sleep metrics with more reliable evidence compared to melatonin.
• There is no safety information available in the reviewed studies.
• The population considered primarily includes patients with sleep disturbances related to ocular disease, particularly those who are totally blind, with no distinct findings provided for different subgroups such as age, gender, or comorbid conditions.