• Sleep-wake disorders

Hetlioz Generic Name & Formulations

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)

Generic Availability


Hetlioz 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


Swallow caps whole. Take 1hr before bedtime, at the same time every night without food. 20mg once daily.


Non-24: not established. SMS: <16yrs: use susp form.

Hetlioz Contraindications

Not Applicable

Hetlioz Boxed Warnings

Not Applicable

Hetlioz 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


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