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About HETLIOZ® (tasimelteon)

About HETLIOZ® (tasimelteon)

HETLIOZ® is a melatonin receptor agonist that is FDA approved for both Non-24-Hour Sleep-Wake Disorder (a serious, chronic circadian rhythm disorder) and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. In addition, HETLIOZ LQ™ oral suspension is approved for treatment of nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age.

There’s an FDA-approved therapy to help you improve nighttime sleep and decrease daytime sleepiness. Ask your doctor about the first and only treatment for people with Non-24 and nighttime sleep disturbances in SMS, called HETLIOZ® (tasimelteon).

HETLIOZ® is the first prescription medication approved to treat Non-24 and nighttime sleep disturbances in SMS.

In clinical studies, HETLIOZ® helped many people living with Non-24 and nighttime sleep disturbances in SMS sleep at night and stay awake during the day. Taken as directed by your doctor, HETLIOZ® may help you break the cycle of disrupted nighttime and unwanted daytime sleep that you've been struggling with.

The most common side effects associated with HETLIOZ® include headache, elevated liver enzymes (ALT), nightmares or abnormal dreams, and upper respiratory or urinary tract infection. These side effects may occur more frequently in patients 65 years of age or older.

HETLIOZSolutions™ was created to support people who have been diagnosed with Non-24 or nighttime sleep disturbances in SMS. The program can assist with coordinating care to help answer insurance questions, as well as provide financial support and educational resources. And most importantly, by letting you know that you are not alone on this journey.

If you have questions, help is available by calling HETLIOZSolutions™ at 1-844-HETLIOZ—that's 1-844-438-5469—from 9:00AM to 8:00PM, Monday through Friday, Eastern Standard Time.

So, to get that important conversation started, here are three accessible PDFs for you to download and share with your doctor.

The first PDF can help you get the conversation with your doctor started.

Use this Doctor Discussion Guide to help you describe your symptoms to your physician, and to discuss diagnosis and potentially starting treatment with HETLIOZ®.
Download Doctor Discussion Guide

The second PDF can help you get your medication delivered.

Because HETLIOZ® is not available at retail pharmacies, there is a special process that you and your doctor will need to follow to have HETLIOZ® delivered to you. Once you have been diagnosed, and your doctor has determined that HETLIOZ® is right for you, you and your healthcare professional will need to fill out and sign the HETLIOZSolutions™ Prescription and Service Request Form.
Download Prescription and Service Request Form

This third PDF provides your doctor with information about Non-24 and HETLIOZ®.

The HETLIOZ® Guide for Your Doctor has been written specifically for doctors, and covers the science behind a circadian rhythm disorder like Non-24 as well as information about the safety and effectiveness of HETLIOZ®. So, be sure to share the information with your doctor if he or she isn't familiar with Non-24 or HETLIOZ®.

If your doctor still has questions about Non-24 and HETLIOZ®, it may be helpful to refer him or her to HETLIOZPRO.com, where we explain Non-24 and how HETLIOZ® can help.
Download HETLIOZ® Guide for Your Doctor

Here's Important Safety Information for
HETLIOZ® (tasimelteon).

Indications
HETLIOZ®(HeT-lee-ōz) [tasimelteon] capsules are indicated for the treatment of:

  • Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
  • Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) patients 16 years of age and older.

HETLIOZ LQ™ (HeT-lee-oz el-Cue) oral suspension is indicated for:

  • Nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age.

Important Safety Information

HETLIOZ® may cause drowsiness. After taking HETLIOZ®, limit your activity to preparing for bed. HETLIOZ® can potentially impair your ability to perform activities that require complete mental alertness.

The most common side effects associated with HETLIOZ® include headache, elevated liver enzymes (ALT), nightmares or abnormal dreams, and upper respiratory or urinary tract infection. These side effects may occur more frequently in patients 65 years of age or older. 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.

Tell your healthcare provider about all of the medicines you're taking. HETLIOZ® should not be taken in combination with fluvoxamine or rifampin.

Tell your healthcare provider about all of your health conditions, including whether you are pregnant, are planning to become pregnant, or are breastfeeding. HETLIOZ® has not been studied in pregnant women.

The safety and effectiveness of HETLIOZ® for the treatment of Non-24-Hour in children 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.

HETLIOZ® is not recommended for use in patients with severe liver problems.

Consumer Important Safety Information

You are encouraged to report side effects of prescription drugs to the FDA. To report side effects, contact Vanda Pharmaceuticals Inc. at 1-844-438-5469 or www.hetlioz.com or FDA at 1-800-FDA-0178 or www.fda.gov/medwatch.

For more information, ask your healthcare provider or call 1-844-HETLIOZ (1-844-438-5469).

This information does not take the place of talking with your healthcare provider for medical advice about your condition or treatment.

Download an accessible PDF or listen to the full US Prescribing Information. You can also hear the full US Prescribing Information by calling 1-844-HETLIOZ (1-844-438-5469).