Treat Non-24 with once-daily dosing

Image of HETLIOZ (tasimelteon) bottle and 20 mg capsule

One HETLIOZ® 20 mg capsule per day*

  • Patients should take HETLIOZ® (tasimelteon) before bedtime, at the same time every night1
  • HETLIOZ® should be taken without food1
  • If patients miss their HETLIOZ® dose at the prescribed time, they should skip the dose that night1
  • After taking HETLIOZ®, patients should limit their activity to preparing for going to bed. HETLIOZ® can potentially impair the performance of activities requiring complete mental alertness1

Clinical effect on sleep cycles requires an adequate trial of up to several (eg, 3) months of daily use with HETLIOZĀ®, due to the nature and variance of circadian rhythms.1,2

*Not actual size.

References: 1. HETLIOZ® [prescribing information]. Vanda Pharmaceuticals Inc. 2014. 2. 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.