Study design—SET: A 6-month, Phase 3, randomized, double-masked, placebo-controlled, multicenter trial. Totally blind patients with Non-24 (N=84) who had non-entrained melatonin circadian rhythms were randomized to receive HETLIOZ® 20 mg (n=42) or placebo (n=42).1,2
SET, Safety and Efficacy of Tasimelteon.
References: 1. HETLIOZ® [prescribing information]. Vanda Pharmaceuticals Inc. 2014. 2. Data on file. Vanda Pharmaceuticals Inc. 2014.
The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® (tasimelteon) than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.
HETLIOZ® (tasimelteon) capsules are indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. HETLIOZ LQ® oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in patients 3 to 15 years of age.
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