Hetlioz

PRODUCT DESCRIPTION

Hetlioz is the brand name of the drug tasimelteon, a prescription medication used to treat non-24-hour sleep-wake disorder (“non-24”).

Non-24 is a condition that causes problems with the timing of sleep.

This disorder occurs almost always in people who are completely blind because light does not enter their eyes, and they cannot synchronize their body clocks to a typical light-dark cycle.

Hetlioz is a melatonin receptor agonist. It works by affecting levels of melatonin, a hormone that regulates the sleep-wake cycle.

The drug was approved by the Food and Drug Administration (FDA) in 2014. It became the first FDA-approved treatment for non-24.

Vanda Pharmaceuticals, Inc. manufactures Hetlioz.

While the medication is only FDA-approved for people with non-24, Hetlioz may also play a role in helping those who suffer insomnia, jet lag, delayed sleep phase syndrome (a condition where patients fall sleep and wake up too late), and advanced sleep phase syndrome (a condition where patients fall asleep and wake up too early).

DOSAGE METHOD

For the treatment of non-24-hour sleep-wake disorder.

Oral dosage

Adults

20 mg PO prior to bedtime at the same time every night; take without food. The therapeutic effect may not occur for weeks or months due to individual differences in circadian rhythms. The risk of adverse reactions may be increased in geriatric patients compared to younger patients because of an approximate 2-fold increase in exposure; however, the manufacturer does not recommend dosage adjustments based upon age.

MAXIMUM DOSAGE

Adults

20 mg/day PO.

Geriatric

20 mg/day PO.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

ADMINISTRATION

Oral Administration

Administration with a high-fat meal affects absorption; tasimelteon should be administered without food.

Administer prior to bedtime. Thereafter, activities should be limited to those necessary to get ready for bed.

Oral Solid Formulations

Oral Capsules:

Do not chew or break capsules; swallow whole.

Take this medication before your normal bedtime. Try to take it at the same time each night. For best results, you should take Hetlioz without food.

You should swallow the capsules whole. Do not crush, break, chew, or open them.

Hetlioz Overdose

If you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center.

Missed Dose of Hetlioz

Hetlioz is usually taken as needed, so you may not be on a regular dosing schedule.

However, don’t take an extra dose of this medicine to make up for a missed one.

NEGATIVE EFFECTS

Common Side Effects of Hetlioz

Some common side effects of Hetlioz may include:

Drowsiness

Nightmares or unusual dreams

Headache

Elevated liver enzymes

Urinary tract infections (UTI)

Symptoms of a cold (such as stuffy nose, sneezing, or sore throat)

Older adults who take Hetlioz may be more likely to suffer from side effects of the drug.

Hetlioz Interactions

Talk to your doctor before taking Hetlioz with other sleeping pills, muscle relaxers, narcotics, anxiety drugs, depression medications, or seizure medicines.

Tell your physician about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you are taking, especially:

Ciprofloxacin (Cipro)

Enzalutamide (Xtandi)

Fluvoxamine (Luvox)

Mitotane (Lysodren)

Rifampin (Rifadin)

St. John’s wort…

Consuming alcohol may increase drowsiness that is caused by Hetlioz.

Talk to your doctor about this risk.

Disclaimer

While every effort has been taken to ensure that the information provided is accurate, up-to-date and complete, Prime Medical Pharma cannot guarantee its accuracy. Please note that the drug information contained herein may be time-sensitive and should not be relied upon beyond the date hereof. This material is intended as a reference resource and should not be used as a substitute for the expertise, skill, knowledge, and judgment of healthcare practitioners in patient care. It is important to note that the absence of a warning for a given drug or combination thereof does not imply safety, effectiveness, or appropriateness for any particular patient. This material does not endorse drugs, diagnose patients, or recommend therapy.