Non-24: It’s about timing

Non-24 is marked by a continuous shift of the sleep-wake cycle1

Raster plot chart comparing the sleep episodes of patients with synchronized versus dyssynchronized sleep-wake cycles Raster plot chart comparing the sleep episodes of patients with synchronized versus dyssynchronized sleep-wake cycles
  • In individuals without Non-24, light is the most potent mechanism for aligning the natural cycle of sleep and wakefulness with the 24-hour day2,3
  • Patients with Non-24 experience shifting sleep-wake cycles, marked by periods of poor sleep, broken up by periods of symptomic relief when the sleep-wake cycle is aligned with the 24-hour day4
  • These periods may last for weeks or months5

Because of individual differences in circadian rhythms,
sleep-wake cycle lengths vary from patient to patient2

Learn how HETLIOZ® (tasimelteon) works
HETLIOZ®—it’s time to increase nighttime sleep

References: 1. Dressman MA, et al. Poster presented at: 26th Annual Meeting of the Associated Professional Sleep Societies, LLC; June 10, 2012; Boston, MA. Poster 49. 2. American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014. 3. Dibner C, et al. Annu Rev Physiol. 2010;72:517-549. 4. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Association; 2013. 5. Lockley SW, et al. In: Kushida C, ed. The Encyclopedia of Sleep. Vol 3. Waltham, MA: Elsevier; 2013:34-40.

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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.