"The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder ("non-24") in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorde"...
Hetlioz Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Hetlioz (tasimelteon) is a melatonin receptor agonist used for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). Common side effects include headache, elevated liver enzymes (ALT), nightmares or abnormal dreams, and upper respiratory or urinary tract infections.
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. Hetlioz may interact with fluvoxamine, or rifampin. Tell your doctor all medications and supplements you use. During pregnancy, Hetlioz should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Hetlioz FDA Prescribing 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)
Additional Hetlioz Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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