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Hetlioz® and Hetlioz LQ™

DrugHetlioz® and Hetlioz LQ™ (tasimelteon capsule and tasimelteon suspension) [Vanda Pharmaceuticals Inc.]

April 2022

Therapeutic area - Sedative Hypnotics

Approval criteria

Universal Criteria

  • Patient does not have severe hepatic impairment (Child-Pugh Class C) AND
  • Patient will avoid concomitant with all of the following:
    • Coadministration with strong CYP1A2 (e.g. fluvoxamine) AND
    • Coadministration with strong CYP3A4 inducers (e.g. rifampin) AND
    • If coadministration with strong CYP1A2 and/or strong CYP3A4 is unavoidable, prescriber attests that the risk of coadministration has been considered AND
  • Patient is not on other concurrent melatonin receptor agonist (e.g., ramelteon) or other prescription sleep aid (e.g., benzodiazepines prescribed for sleep, nonbenzodiazepine hypnotics “Z” drugs [zolpidem, eszopiclone, zaleplon], orexin receptor antagonists [leborexant, suvorexant]) AND

Non-24-Hour Sleep-Wake Disorder

  • Patient is at least 18 years old and the request is for Hetlioz (tasimelteon capsule) OR

Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS)

  • Patient is at least 16 years old and the request is for Hetlioz (tasimelteon capsule) OR
  • Patient is 3 years old to 15 years old and the request is for Hetlioz LQ (tasimelteon suspension)

Quantity limits

  • Capsule, 20 mg: 1 capsule per day
  • Oral suspension, 4 mg/mL: 20 mg per day. Patient’s weight (in kg) must be submitted at time of request


MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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