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Hetlioz Generic Name & Formulations
Legal Class
Rx
General Description
Tasimelteon 20mg; hard gel caps.
Pharmacological Class
Melatonin receptor agonist.
See Also
How Supplied
Caps—30; LQ—48mL, 158mL (w. bottle adapter, oral syringe)
Manufacturer
Generic Availability
NO
Hetlioz Indications
Indications
Non-24-hour sleep-wake disorder (Non-24) in adults. Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients ≥16yrs of age.
Hetlioz Dosage and Administration
Adult
Swallow caps whole. Take 1hr before bedtime, at the same time every night without food. 20mg once daily.
Children
Non-24: not established. SMS: <16yrs: use susp form.
Hetlioz Contraindications
Not Applicable
Hetlioz Boxed Warnings
Not Applicable
Hetlioz 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 Pharmacokinetics
See Literature
Hetlioz 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 Adverse Reactions
Adverse Reactions
Headache, increased ALT, nightmares or unusual dreams, upper respiratory tract infection, urinary tract infection; somnolence.
Hetlioz Clinical Trials
See Literature
Hetlioz Note
Not Applicable
Hetlioz Patient Counseling
See Literature
