WARNINGS
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.
USES
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.
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.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
HETLIOZ Capsules
Store HETLIOZ capsules at controlled room temperature, 20-degrees C to 25-degrees C (68-degrees F to 77-degrees F); excursions permitted to 15-degrees C to 30-degrees C (59-degrees F to 86-degrees F). Protect from exposure to light and moisture.
HETLIOZ LQ Oral Suspension
Store HETLIOZ LQ oral suspension at refrigerated temperature 5-degrees C (41-degrees F); excursions permitted to 2-degrees C to 8-degrees C (36-degrees F t o 46-degrees F).
NOTES
Medication Guide: revision date 01/2023
Prescribing Information: revision date 01/2024
1.) Strong CYP1A2 Inhibitors (e.g., fluvoxamine)
Avoid use of HETLIOZ in combination with fluvoxamine or other strong CYP1A2 inhibitors because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions.
2.) Strong CYP3A4 Inducers (e.g., rifampin)
Avoid use of HETLIOZ in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy.
3.) Beta-adrenergic Receptor Antagonists (e.g., acebutolol, metoprolol)
Beta-adrenergic receptor antagonists have been shown to reduce the production of melatonin via specific inhibition of beta-1 adrenergic receptors. Nighttime administration of beta-adrenergic receptor antagonists may reduce the efficacy of HETLIOZ.
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.
