FDA Approves First Drug to Treat Circadian Rhythm Sleep Disorder in the Blind — Physician’s First Watch
FDA Approves First Drug to Treat Circadian Rhythm Sleep Disorder in the Blind
By Amy Orciari Herman
The melatonin receptor agonist tasimelteon (Hetlioz) has been approved to treat non-24 sleep-wake disorder in totally blind individuals, the FDA announced on Friday. The drug should be taken each night before bedtime.
In two placebo-controlled clinical trials comprising roughly 100 totally blind patients with non-24 disorder, tasimelteon significantly increased the duration of nighttime sleep and decreased the duration of daytime sleep. The most frequent side effects included headache, elevated alanine aminotransferase levels, nightmares, and disrupted sleep.
Tasimelteon can impair mental alertness; accordingly, patients should limit their activities after taking the drug.