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Drug updated on 4/17/2024

Dosage FormCapsule (oral: 20 mg); Suspension (oral: 4 mg/mL)
Drug ClassMelatonin receptor agonists
Ongoing and
Completed Studies


  • Indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults.
  • Indicated for the nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.
  • Indicated for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age.

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  • Tasimelteon (Hetlioz) is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder in adults, nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) patients aged 16 and older, and similar sleep disturbances in SMS pediatric patients aged between 3 to 15 years.
  • A study compared the effectiveness and safety of tasimelteon with other pharmacological agents like melatonin for treating sleep disorders related to ocular disease.
  • The population studied consisted of totally blind individuals who experience a high incidence of sleep problems due to their inability to receive light input, which is essential for regulating circadian rhythms.
  • In terms of effectiveness, both melatonin and tasimelteon show promise; however, tasimelteon exhibits significant improvement in the entrainment or synchronization of the internal body clock with the day-night cycle. It also improves subjective measures such as the midpoint timing of sleep, lower quartile nighttime sleeping time, and upper quartile daytime sleeping time, indicating its potential efficacy over melatonin.
  • Evidence on safety suggests limited side effects for both drugs but highlights methodological limitations within studies, including risks associated with inadequate reporting procedures leading to bias. There is also a risk from post-enrollment outcome alterations causing reporting bias, specifically noted during the tasimelteon trial.
  • Despite these promising results regarding Hetlioz's efficacy against conditions like Non–24-hour Sleep–Wake Disorder & SMS, particularly caused by ocular diseases disrupting circadian rhythms, caution is advised due to potential biases, suggesting further research is necessary before making definitive conclusions on its superiority over existing treatments using Melatonin.

Product Monograph / Prescribing Information

Document TitleYearSource
Hetlioz (tasimelteon) prescribing information.2024Vanda Pharmaceuticals Inc., Washington, D.C.

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines