Hetlioz Lq Generic Name & Formulations
Legal Class
Rx
General Description
Tasimelteon 4mg/mL; oral susp; cherry flavor; contains polysorbate 80.
Pharmacological Class
Melatonin receptor agonist.
See Also
How Supplied
Caps—30; LQ—48mL, 158mL (w. bottle adapter, oral syringe)
Manufacturer
Generic Availability
NO
Hetlioz Lq Indications
Indications
Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 3–15yrs of age.
Hetlioz Lq Dosage and Administration
Adult
Not applicable.
Children
<3yrs: not established. Take 1hr before bedtime, at the same time every night without food. 3–15yrs (≤28kg): 0.7mg/kg once daily; (>28kg): 20mg once daily.
Hetlioz Lq Contraindications
Not Applicable
Hetlioz Lq Boxed Warnings
Not Applicable
Hetlioz Lq Warnings/Precautions
Warnings/Precautions
Caps and oral susp are not interchangeable. Risk of somnolence. Severe hepatic impairment (Child-Pugh C): not recommended. Smokers. Elderly. Pregnancy. Nursing mothers.
Hetlioz Lq Pharmacokinetics
See Literature
Hetlioz Lq Interactions
Interactions
Avoid concomitant strong CYP1A2 inhibitors (eg, fluvoxamine), strong CYP3A4 inhibitors (eg, ketoconazole), or others; effects may be increased. Avoid concomitant strong CYP3A4 inducers (eg, rifampin) or others; effects may be reduced. Smoking or nighttime administration of beta-blockers may reduce tasimelteon effects. Additive effects with alcohol.
Hetlioz Lq Adverse Reactions
Adverse Reactions
Headache, increased ALT, nightmares or unusual dreams, upper respiratory tract infection, urinary tract infection; somnolence.
Hetlioz Lq Clinical Trials
See Literature
Hetlioz Lq Note
Not Applicable
Hetlioz Lq Patient Counseling
See Literature