The impact of Non-24 can be severe, yet the disorder may be underdiagnosed

It is highly prevalent in individuals who are totally blind1,2

  • Onset can occur at any age in totally blind individuals after the loss of light perception and, if left untreated, the course of Non-24 becomes chronic3

Up to 70%

of people who are totally blind have Non-24
Graphic which shows that Non-24-Hour Sleep-Wake Disorder, or Non-24, is very common among patients who are totally blind. Approximately 130,000 people who are totally blind have no light perception (reference 3,4). Up to 95,000 people who are totally blind have Non-24

“Most totally blind people live with circadian rhythms that are not synchronised with the 24 hour world, inducing a disorder that some patients describe as a disability worse than the blindness itself.”
-Steven Lockley et al. on Non-244

References: 1. Sack RL, et al. Sleep Med Rev. 2001;5(3):189-206. 2. Dressman MA, et al. Poster presented at: 26th Annual Meeting of the Associated Professional Sleep Societies, LLC; June 10, 2012; Boston, MA. Poster 49. 3. American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014. 4. Lockley SW, et al. Lancet. 2015;386(10005):1754-1764.

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.