WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Tasimelteon is a central nervous system agent that is FDA approved for the treatment of non-24-hour sleep-wake disorder. Common adverse reactions include headache, urinary tract infection, upper respiratory tract infection, abnormal dreams, increased liver enzymes.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
Dosage
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, drug effect may not occur for weeks or months.
DOSAGE FORMS AND STRENGTHS
Capsules: 20 mg size 1 dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tasimelteon in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tasimelteon in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Tasimelteon in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tasimelteon in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tasimelteon in pediatric patients.
Contraindications
None
Warnings
Somnolence
After taking HETLIOZ, patients should limit their activity to preparing for going to bed. HETLIOZ can potentially impair the performance of activities requiring complete mental alertness.
Adverse Reactions
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.
This image is provided by the National Library of Medicine.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Tasimelteon in the drug label.
Drug Interactions
Strong CYP1A2 Inhibitors (e.g., fluvoxamine)
Avoid use of HETLIOZ in combination with fluvoxamine or other strong CYP1A2 inhibitors because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions [see Clinical Pharmacology (12.3)].
Strong CYP3A4 Inducers (e.g., rifampin)
Avoid use of HETLIOZ in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy.
