Generic Name
Tasimelteon
Brand Names
Hetlioz, Hetlioz LQ
FDA approval date: April 04, 2014
Classification: Melatonin Receptor Agonist
Form: Suspension, Capsule
What is Hetlioz (Tasimelteon)?
HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder in adults Nighttime sleep disturbances in Smith-Magenis Syndrome in patients 16 years of age and older HETLIOZ LQ oral suspension is indicated for the treatment of: Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age
Approved To Treat
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Related Clinical Trials
A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Summary: This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.
A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
Summary: This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.
A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Participants with Delayed Sleep-Wake Phase Disorder (DSWPD)
Summary: This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.
Related Latest Advances
Brand Information
Hetlioz (tasimelteon)
1DOSAGE FORMS AND STRENGTHS
Capsules: 20 mg size 1 dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white.
Oral suspension: 4 mg/mL white to slightly yellow opaque suspension in 48 mL or 158 mL bottles.
2CONTRAINDICATIONS
None.
3OVERDOSAGE
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.
4DESCRIPTION
HETLIOZ (contains tasimelteon) a melatonin receptor agonist, chemically designated as (1
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.
5HOW SUPPLIED/STORAGE AND HANDLING
HETLIOZ Capsules
20 mg capsules are available as size 1, dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white, containing 20 mg of tasimelteon per capsule.
20 mg capsules are available as size 1, dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white, containing 20 mg of tasimelteon per capsule.
- NDC 43068-220-01 Bottles of 30
HETLIOZ LQ Oral Suspension
4 mg/mL white to slightly yellow opaque suspension. Each bottle has a child resistant cap and packaged in a carton. Each carton contains a bottle of HETLIOZ LQ oral suspension, a 5 mL oral dosing syringe and a press-in bottle adapter.
4 mg/mL white to slightly yellow opaque suspension. Each bottle has a child resistant cap and packaged in a carton. Each carton contains a bottle of HETLIOZ LQ oral suspension, a 5 mL oral dosing syringe and a press-in bottle adapter.
- NDC 43068-304-02 Bottles of 48 mL
- NDC 43068-304-06 Bottles of 158 mL
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling for HETLIOZ LQ oral suspension, if appropriate (
- Advise patients to limit their activities to preparing for going to bed after taking HETLIOZ capsules or HETLIOZ LQ oral suspension because HETLIOZ can potentially impair the performance of activities requiring complete mental alertness
- Administration Information for HETLIOZ capsules and HETLIOZ LQ oral suspension
- Non-24 (HETLIOZ capsules)
Distributed by:
Vanda, HETLIOZ, and HETLIOZ LQ are trademarks or registered trademarks of Vanda Pharmaceuticals Inc. in the United States and other countries.
7PRINCIPAL DISPLAY PANEL - NDC 43068-220-01 - 20 mg Bottle
8PRINCIPAL DISPLAY PANEL - NDC 43068-304-02 - 48 mL Bottle Label
9PRINCIPAL DISPLAY PANEL - NDC 43068-304-02 - 48 mL Carton Label
10PRINCIPAL DISPLAY PANEL - NDC 43068-304-06 - 158 mL Bottle Label
11PRINCIPAL DISPLAY PANEL - NDC 43068-304-06 - 158 mL Carton Label
