hetlioz
Hetlioz (Tasimelteon) is a melatonin receptor agonist used to treat Circadian Rhythm Sleep Disorders.
Tasimelteon · by Vanda Pharms Inc
Key facts
- Active ingredient
- Tasimelteon
- Drug class
- Melatonin Receptor Agonist
- Form
- Capsule
- Strength
- Tasimelteon 20MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- circadian rhythm sleep disorders
- Manufacturer
- Vanda Pharms Inc
- What the pharmacy pays
- ~$11350.80 for 30 — not your price
- FDA application
- NDA205677
What is Hetlioz?
From the FDA label:HETLIOZ (contains tasimelteon) a melatonin receptor agonist, chemically designated as (1 R , 2 R )-N-[2-(2,3-dihydrobenzofuran-4-yl)cyclopropylmethyl]propanamide, containing two chiral centers. The molecular formula is C 15 H 19 NO 2 , and the molecular weight is 245.32. The structural formula is: Tasimelteon is a white to off-white crystalline powder. It is very slightly soluble in cyclohexane, slightly soluble in water and 0.1 N hydrochloric acid, and freely soluble or very soluble in methanol, 95% ethanol, acetonitrile, isopropanol, polyethylene glycol 300, propylene glycol and ethyl acetate. HETLIOZ capsules are intended for oral administration. Each capsule contains 20 mg of tasimelteon and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. Each hard gelatin capsule consists of FD&C Blue #1, FD&C Red #3, and FD&C Yellow #6, gelatin, and titanium dioxide. HETLIOZ LQ oral suspension contains 4 mg of tasimelteon per mL of suspension and the following inactive ingredients: ascorbic acid, cherry flavor, mannitol, microcrystalline cellulose/carboxymethylcellulose sodium, polysorbate 80, sodium benzoate, sodium chloride, sucrose, sucralose, and water. Chemical Structure
How to use
Indicated Population Dosage Form Body Weight Recommended Dosage Non-24 ( 2.2 ) Adults Capsules Not applicable 20 mg one hour prior to bedtime Nighttime sleep disturbances in SMS ( 2.3 ) Patients 16 years of age and older Capsules Not applicable 20 mg one hour prior to bedtime Pediatric Patients 3 to 15 years of age Oral Suspension ≤ 28 kg 0.7 mg/kg one hour before bedtime ≥ 28 kg 20 mg one hour prior to bedtime HETLIOZ capsules and HETLIOZ LQ oral suspension are not substitutable ( 2.1 ) Administer at the same time every night ( 2.2 , 2.3 ) Take without food ( 2.4 ) 2.1 Non-Interchangeability between HETLIOZ Capsules and HETLIOZ LQ Oral Suspension HETLIOZ capsules and HETLIOZ LQ oral suspension are not substitutable [see Clinical Pharmacology ( 12.3 )]. 2.2 Recommended Dosage for HETLIOZ Capsules for Non-24 Adults The recommended dosage of HETLIOZ capsules in adults is 20 mg one hour before bedtime, at the same time every night. Because of individual differences in circadian rhythms, drug effect may not occur for weeks or months. 2.3 Recommended Dosage for HETLIOZ Capsules and HETLIOZ LQ Oral Suspension for Nighttime Sleep Disturbances in SMS Patients 16 years of Age and Older The recommended dosage of HETLIOZ capsules in patients 16 years and older is 20 mg one hour before bedtime, at the same time every night. Pediatric Patients 3 Years to 15 Years of Age The recommended…
Side effects
The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc. at 1-844-438-5469 or www.hetlioz.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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. More than 2080 subjects have been treated with at least one dose of HETLIOZ, of which more than 380 have been treated for > 26 weeks and more than 170 have been treated for > 1 year. Non-24-Hour Sleep-Wake Disorder (Non-24) 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.…
Warnings
Important safety information
May cause somnolence: After taking HETLIOZ, patients should limit their activity to preparing for going to bed, because HETLIOZ can impair the performance of activities requiring complete mental alertness ( 5.1 ) 5.1 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.
Who should not take Hetlioz
None. None ( 4 )
Overdose — what happens if you take too much
There is limited premarketing clinical experience with the effects of an overdosage of HETLIOZ. As with the management of any overdose, general symptomatic and supportive measures should be used, along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Respiration, pulse, blood pressure, and other appropriate vital signs should be monitored, and general supportive measures employed. While hemodialysis was effective at clearing HETLIOZ and the majority of its major metabolites in patients with renal impairment, it is not known if hemodialysis will effectively reduce exposure in the case of overdose. As with the management of any overdose, the possibility of multiple drug ingestion should be considered. Contact a poison control center for current information on the management of overdose.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Strong CYP1A2 inhibitors (e.g., fluvoxamine): Avoid use of HETLIOZ in combination with strong CYP1A2 inhibitors because of increased exposure ( 7.1 , 12.3 ) Strong CYP3A4 inducers (e.g., rifampin): Avoid use of HETLIOZ in combination with rifampin or other CYP3A4 inducers, because of decreased exposure ( 7.2 , 12.3 ) 7.1 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 )]. 7.2 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 [see Clinical Pharmacology ( 12.3 )]. 7.3 Beta-adrenergic Receptor Antagonists (e.g., acebutolol, metoprolol) Beta-adrenergic receptor antagonists have been shown to reduce the production of melatonin via specific inhibition of beta-1 adrenergic receptors. Nighttime administration of beta-adrenergic receptor antagonists may reduce the efficacy of HETLIOZ.
Storing Hetlioz, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “After opening, discard after 5 weeks (for the 48 mL bottle) and after 8 weeks (for the 158 mL bottle).”
- “HETLIOZ Capsules Store HETLIOZ capsules at controlled room temperature, 20°C to25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].”
- “Store HETLIOZ LQ Oral suspension at refrigerated temperature 5°C (41°F); excursions permitted to 2°C to 8°C (36°F t o 46°F).”
Drug class
May treat (source: NIH RxClass)
See how Hetlioz ranks — best-rated melatonin receptor agonist for:
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- What does Hetlioz treat?
- Hetlioz (Tasimelteon) may be used to treat circadian rhythm sleep disorders, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Hetlioz cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $11350.80 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Rozerem — about $21.45 on the same basis.
- Is there a coupon or discount for Hetlioz?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Hetlioz. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Hetlioz?
- Hetlioz is marketed by Vanda Pharms Inc. You can see Vanda Pharms Inc's full profile, rating, and other products on pharmaranks.
- Is Hetlioz a brand-name or generic drug?
- Hetlioz is a brand-name product with the active ingredient Tasimelteon.
- Is Hetlioz available over the counter?
- No. Hetlioz is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Hetlioz come in?
- Hetlioz is currently marketed as capsule, per the FDA's National Drug Code Directory.
- What class of drug is Hetlioz?
- Hetlioz is classified as melatonin receptor agonist, per the FDA's Established Pharmacologic Class.
- Is Hetlioz FDA-registered?
- Hetlioz is on record with the U.S. FDA under application number NDA205677. You can verify this on its official FDA label.
- Is Hetlioz safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Hetlioz. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Hetlioz?
- Hetlioz's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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