Summary

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• This summary is based on the review of two systematic review(s)/meta-analysis(es). ^[1-2]
• In patients with Smith-Magenis Syndrome (SMS), tasimelteon showed significant effectiveness in improving sleep quality, with a DDSQ50 improvement of 0.4 (p = 0.0139), and total sleep time, increasing by 21.1 minutes (p = 0.0134), as measured by actigraphy. Additionally, secondary outcomes showed significant improvements in average sleep quality and total sleep time in the worst 50% of nights.
• For individuals with Non-24-Hour Sleep-Wake Disorder, tasimelteon demonstrated significant improvements in night-time sleep, reduced daytime naps, and effectively entrained sleep-wake cycles to a 24-hour rhythm, thereby enhancing overall sleep timing and stability.
• In the study on Smith-Magenis Syndrome (SMS), adverse events for tasimelteon were comparable to placebo, indicating a similar safety profile without significant safety concerns noted.
• In a driving performance study for Non-24-Hour Sleep-Wake Disorder, tasimelteon showed no clinically meaningful or statistically significant impairment in next-day driving performance compared to placebo, highlighting its safety advantage over zopiclone, which was associated with impaired next-day driving abilities.
• Tasimelteon demonstrated clinically relevant improvements in sleep quality and total sleep time for patients with Smith-Magenis Syndrome (ages 3-39) with genetically confirmed diagnoses, as well as maintained safety without impairing next-day performance in adult subjects with Non-24-Hour Sleep-Wake Disorder, important for individuals who require daytime alertness.