Accessibility Policy

Vanda Pharmaceuticals Inc. creates websites that are accessible to people with disabilities. This one has been designed to help educate people about HETLIOZ® (tasimelteon), and it is intended for patients with Non-24—the majority of whom are totally blind—as well as their family, friends, doctors, and caregivers.

This website complies with all three levels of the World Wide Web Consortium (W3C) Web Access Initiative Guidelines and Recommendations for Content and Authoring Tools. We support and comply with AFB's "Policy Statement for Assuring That Materials Produced by the American Foundation for the Blind Are Accessible to People Who Are Blind or Visually Impaired."

This website was created to provide the easiest possible access for people who are blind, with visuals adapted for sighted people. It includes enhancements that promote accessibility and usability for blind or visually impaired users.

In its policies and its activities, Vanda asserts that all websites should be accessible to people with disabilities, and we urge all web developers to create sites that are accessible to all.

Though this site includes links to other websites, we cannot guarantee that they comply with web accessibility standards. If you find web accessibility problems, please contact each website's owners and ask that they comply with accessibility recommendations.

We appreciate any and all feedback. Please contact us at accessibility@vandapharma.com or call 1-844-HETLIOZ (1-844-438-5469) Monday through Friday from 9 AM to 8 PM, Eastern Standard Time.

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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.