Here's Important Safety Information for HETLIOZ® (tasimelteon).
HETLIOZ® is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
Important Safety Information
HETLIOZ® (HeT-lee-ōz) is a prescription medication used to treat Non-24-Hour Sleep-Wake Disorder (Non-24).
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.
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. HETLIOZ® should be used during pregnancy only if the potential benefit justifies the potential risks.
HETLIOZ® has not been studied in children and it is not recommended for use in patients with severe liver problems.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, call 1-800-FDA-1088, or report by fax at 1-800-FDA-0178.
For more information, ask your doctor or call 1-844-HETLIOZ (1-844-438-5469).
This information does not take the place of talking with your doctor for medical advice about your condition or treatment.
Download an accessible PDF or listen to the full Prescribing Information. You can also hear the full Prescribing Information by calling 1-844-HETLIOZ (1-844-438-5469).