Role of light perception in Non-24

In sighted individuals: Daily exposure to the light-dark cycle synchronizes the circadian clock with the 24-hour day.1,2

Ability to
perceive light

Graphic of synchronized circadian rhythm in patients with light perception

SCN, suprachiasmatic nucleus.

The SCN controls daily circadian rhythms, including the production of melatonin and cortisol, as well as body temperature. Lack of synchronization of the SCN results in the misalignment of these circadian rhythms, including the sleep-wake cycle, which can differ between individuals.3

In most people who are totally blind: Without light perception, sleep-wake cycles shift, often becoming dyssynchronized with the 24-hour day.1

Inability to
perceive light

Graphic of dyssynchronized circadian rhythm in patients who lack the ability to perceive light

Lack of light perception can lead to the dyssynchronization of the endogenous circadian clock with the 24-hour light-dark cycle2

HETLIOZ® (tasimelteon)—it’s time to increase nighttime sleep
Identifying Non-24 in your practice

References: 1. Lockley SW, et al. In: Kushida C, ed. The Encyclopedia of Sleep. Vol 3. Waltham, MA: Elsevier; 2013:34-40. 2. American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014. 3. Sack RL, et al. J Clin Endocrinol Metab. 1992;75(1):127-134.

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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.