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

Learn how HETLIOZ® (tasimelteon) works
Identifying Non-24 in your practice

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.

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Healthcare Provider 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® (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.

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.Adverse reactions were similar in patients treated for Non-24 and patients with SMS treated for nighttime sleep disturbances. Adverse reactions were also similar in pediatric patients (3 years to 15 years) who received HETLIOZ LQ® oral suspension, and patients ≥16 years of age who received HETLIOZ capsules
  • 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. 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.
  • The safety and effectiveness of HETLIOZ® for the treatment of Non-24 in pediatric patients have not been established. The safety and effectiveness of HETLIOZ LQ® oral suspension for the treatment of nighttime sleep disturbances in SMS have been established in pediatric patients 3 years and older.
  • To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc. at 1-844-438-5469 or www.hetlioz.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full US Prescribing Information.