HETLIOZ SIDE EFFECTS
- Generic Name: tasimelteon capsules
- Brand Name: Hetlioz
- Drug Class: , Melatonin Receptor Agonists
SIDE EFFECTS
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. | ||
SRC: NLM .