🏅 FDA Orphan Designation

HETLIOZ

tasimelteon

Manufacturer: Vanda Pharmaceuticals, Inc.

Indicated for:

Non-24-hour sleep-wake syndromeSmith-Magenis syndrome

FDA-Approved Indications (2)

Non-24-hour sleep-wake syndrome

HETLIOZ capsules are indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults

Population: adults

Smith-Magenis syndrome

HETLIOZ capsules are indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older

Population: patients ≥16 years

Indications & Usage

1 INDICATIONS AND USAGE HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder (Non-24) in adults ( 1 ) Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older ( 1 ) HETLIOZ LQ oral suspension is indicated for the treatment of: Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age ( 1 ) 1.1 Non-24-Hour Sleep-Wake Disorder (Non-24) HETLIOZ capsules are indicated for the treatment of Non-24 in adults. 1.2 Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS) HETLIOZ capsules are indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older. HETLIOZ LQ oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age.

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HETLIOZ

Vanda Pharmaceuticals, Inc.

Hetlioz, Hetlioz LQ

Vanda

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.