• Generic Name: tasimelteon capsules
  • Brand Name: Hetlioz
  • Drug Class: , Melatonin Receptor Agonists
Last updated on MDtodate: 10/6/2022


Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 1346 subjects were treated with at least one dose of HETLIOZ, of which 139 were treated for > 26 weeks and 93 were treated for > 1 year.

A 26-week, parallel-arm placebo-controlled study (Study 1) evaluated HETLIOZ (n=42) compared to placebo (n=42) in patients with Non-24. A randomized-withdrawal, placebo-controlled study of 8 weeks duration (Study 2) also evaluated HETLIOZ (n=10), compared to placebo (n=10), in patients with Non-24.

In placebo-controlled studies, 6% of patients exposed to HETLIOZ discontinued treatment due to an adverse event, compared with 4% of patients who received placebo.

Table 1 shows the incidence of adverse reactions from Study 1.

Table 1: Adverse Reactions in Study 1

HETLIOZ N=42 Placebo N=42
Headache 17 % 7 %
Alanine aminotransferase increased 10 % 5 %
Nightmare/abnormal dreams 10 % 0 %
Upper respiratory tract infection 7 % 0 %
Urinary tract infection 7 % 2 %
*Adverse reactions with an incidence > 5% and at least twice as high on HETLIOZ than on placebo are displayed.