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Important Safety Information for HETLIOZ™

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 if you are pregnant, planning to become pregnant, or 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, 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.

Please see full Prescribing Information.