HETLIOZ® (tasimelteon) offers a novel approach to the treatment of Non-24

Light perception and the sleep-wake cycle1,2

  • Daily exposure to the light-dark cycle synchronizes the circadian clock with the 24-hour day1,2
  • Without light perception, sleep-wake cycles shift, becoming dyssynchronized with the 24-hour day1

HETLIOZ® is an agonist at the MT1 and MT2 receptors, which are thought to be involved in the control of circadian rhythms3

  • HETLIOZ® (tasimelteon) binds to melatonin receptors and exhibits a greater affinity for the MT2 as compared to the MT1 receptor3
  • The precise mechanism by which HETLIOZ® exerts its therapeutic effect in patients with Non-24 is not known3

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.

Important Safety Information

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.

Indication

HETLIOZ® is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).

Important Safety Information

  • HETLIOZ® may cause somnolence: After taking HETLIOZ®, patients should limit their activity to preparing for going to bed, because HETLIOZ® can potentially impair the performance of activities requiring complete mental alertness.
  • The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® 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.
  • Use of HETLIOZ® should be avoided in combination with fluvoxamine or other strong CYP1A2 inhibitors, because of a potentially large increase in exposure of HETLIOZ®, and a greater risk of adverse reactions. HETLIOZ® should be avoided in combination with rifampin or other CYP3A4 inducers, because of a potentially large decrease in exposure of HETLIOZ®, with reduced efficacy.
  • There are no adequate and well-controlled studies of HETLIOZ® in pregnant women. Based on animal data, HETLIOZ® may cause fetal harm. HETLIOZ® should be used during pregnancy only if the potential benefit justifies the potential risks. Caution should be exercised when HETLIOZ® is administered to a nursing woman.
  • HETLIOZ® has not been studied in patients with severe hepatic impairment and is not recommended in these patients.
  • Safety and effectiveness of HETLIOZ® in pediatric patients have not been established.

Please see full Prescribing Information.