Hetlioz

Last reviewed on RxList: 12/10/2020
Hetlioz Side Effects Center

What Is Hetlioz?

Hetlioz (tasimelteon) is a melatonin receptor agonist used for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).

What Are Side Effects of Hetlioz?

Common side effects of Hetlioz include:

Dosage for Hetlioz

The recommended dosage of Hetlioz is 20 mg per day taken before bedtime, at the same time every night. Because of individual differences in circadian rhythms, the drug effect may not occur for weeks or months.

What Drugs, Substances, or Supplements Interact with Hetlioz?

Hetlioz may interact with fluvoxamine, or rifampin. Tell your doctor all medications and supplements you use.

Hetlioz During Pregnancy and Breastfeeding

During pregnancy, Hetlioz should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Hetlioz (tasimelteon) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Why do we sleep? See Answer
Hetlioz Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pain or burning when you urinate.

Side effects may be more likely in older adults.

Common side effects may include:

  • headache;
  • abnormal liver function tests;
  • strange dreams, nightmares; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Hetlioz (Tasimelteon Capsules)

SLIDESHOW

Sleep Disorders: Foods That Help Sleep or Keep You Awake See Slideshow
Hetlioz Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 1346 subjects were treated with at least one dose of HETLIOZ, of which 139 were treated for > 26 weeks and 93 were treated for > 1 year.

A 26-week, parallel-arm placebo-controlled study (Study 1) evaluated HETLIOZ (n=42) compared to placebo (n=42) in patients with Non-24. A randomized-withdrawal, placebo-controlled study of 8 weeks duration (Study 2) also evaluated HETLIOZ (n=10), compared to placebo (n=10), in patients with Non-24.

In placebo-controlled studies, 6% of patients exposed to HETLIOZ discontinued treatment due to an adverse event, compared with 4% of patients who received placebo.

Table 1 shows the incidence of adverse reactions from Study 1.

Table 1: Adverse Reactions in Study 1

  HETLIOZ N=42 Placebo N=42
Headache 17 % 7 %
Alanine aminotransferase increased 10 % 5 %
Nightmare/abnormal dreams 10 % 0 %
Upper respiratory tract infection 7 % 0 %
Urinary tract infection 7 % 2 %
*Adverse reactions with an incidence > 5% and at least twice as high on HETLIOZ than on placebo are displayed.

Read the entire FDA prescribing information for Hetlioz (Tasimelteon Capsules)

© Hetlioz Patient Information is supplied by Cerner Multum, Inc. and Hetlioz Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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