Hetlioz Lq

— THERAPEUTIC CATEGORIES —
  • Sleep-wake disorders

Hetlioz Lq Generic Name & Formulations

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)

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