Medical Editor: John P. Cunha, DO, FACOEP
- elevated liver enzymes (alanine aminotransferase, or ALT) in the blood,
- nightmares or abnormal dreams,
- disturbed night’s sleep,
- upper respiratory tract infections, or
- urinary tract infections.
The recommended dosage of Hetlioz is 20 mg per day taken before bedtime, at the same time every night. Because of individual differences in circadian rhythms, the drug effect may not occur for weeks or months. Hetlioz may interact with fluvoxamine, or rifampin. Tell your doctor all medications and supplements you use. During pregnancy, Hetlioz should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Hetlioz (tasimelteon) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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.|
Read the entire FDA prescribing information for Hetlioz (Tasimelteon Capsules)