References: 1. American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014. 2. Lockley SW, et al. In: Kushida C, ed. The Encyclopedia of Sleep. Vol 3. Waltham, MA: Elsevier; 2013:34-40. 3. HETLIOZ® [prescribing information]. 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® is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
Please see full US Prescribing Information.