It’s time to treat Non-24 with HETLIOZ® (tasimelteon)

In RESET, a randomized withdrawal study of the safety and efficacy of tasimelteon, HETLIOZ® maintained significant decreases in daytime sleep duration and increases in nighttime sleep duration, as compared to placebo1


HETLIOZ (tasimelteon) Efficacy Clinical Data – RESET HETLIOZ (tasimelteon) Efficacy Clinical Data – RESET
  • Patients were treated with HETLIOZ® (tasimelteon) and then randomized to receive placebo or continue treatment with HETLIOZ®1

Study design—RESET: Patients who received HETLIOZ® and had entrained melatonin circadian rhythms (N=20) were randomized in RESET to receive placebo (n=10) or continue treatment with HETLIOZ® 20 mg (n=10) for 8 weeks. Entrainment is the calculated time of peak melatonin levels occurring at approximately the same time of day.1

RESET, Randomized Withdrawal Study of the Efficacy and Safety of Tasimelteon.

HETLIOZ® clinical trial program: 2 pivotal, Phase 3, multicenter, randomized, double-masked, placebo-controlled trials in patients who are totally blind with Non-24 1,2

  • Efficacy assessments were based on the 25% of nights with the least nighttime sleep and the 25% of days with the most daytime sleep1
  • Patients were more symptomatic when sleep-wake cycles were most misaligned with the 24-hour day1

Study 2: RESET2

  • HETLIOZ® patients with entrained* melatonin circadian rhythms were randomized in RESET2
Graphic of Study 2 design (RESET), an 8-week, randomized withdrawal trial with 10 patients on HETLIOZ (tasimelteon) 20 mg versus 10 patients on placebo Randomized Withdrawal study of the Efficacy and Safety of Tasimelteon

*Patients in whom the calculated time of peak melatonin levels occurred at approximately the same time of day.1

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

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 LQTM 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 LQTM 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 LQTM 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.