Hetlioz® and Hetlioz LQ™

Drug - Hetlioz® 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)

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