Hetlioz

Q: Is HETLIOZ a controlled substance?

<p>Unlike many other <a href="https://www.withpower.com/clinical-trials/sleep">sleep</a> <a href="https://www.withpower.com/clinical-trials/aids">aids</a>, tasimelteon is not a controlled substance under the Controlled Substances Act.</p>

Sleep Disorders, Circadian Rhythm, Insomnia, Smith-Magenis Syndrome

Treatment

4 Active Studies for Hetlioz

Treatment for

Sleep Disorders, Circadian Rhythm

What is Hetlioz

TasimelteonThe Generic name of this drug

Treatment SummaryTasimelteon is a drug used to treat Non-24-Hour Sleep-Wake Disorder (N24HSWD) which mainly affects people who are blind. People with this condition often have trouble sleeping at night and feeling tired during the day. Tasimelteon helps to regulate the body’s circadian rhythm by activating melatonin receptors in the brain, allowing people with N24HSWD to sleep better. It is the only medication approved by the FDA specifically for this condition and was granted orphan drug status in 2010.

Hetliozis the brand name

image of different drug pills on a surface

Hetlioz Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Hetlioz

Tasimelteon

2014

Effectiveness

How Hetlioz works in the bodyTasimelteon activates two types of melatonin receptors in the body.

When to interrupt dosage

The suggested measure of Hetlioz is contingent upon the determined condition. The quantity of dosage can be found in the table below, contingent upon the approach of administration (e.g. Suspension - Oral or Oral).

Condition

Dosage

Administration

Sleep Disorders, Circadian Rhythm

, 20.0 mg, 4.0 mg/mL

, Oral, Capsule, Capsule - Oral, Suspension - Oral, Suspension

Insomnia

, 20.0 mg, 4.0 mg/mL

, Oral, Capsule, Capsule - Oral, Suspension - Oral, Suspension

Smith-Magenis Syndrome

, 20.0 mg, 4.0 mg/mL

, Oral, Capsule, Capsule - Oral, Suspension - Oral, Suspension

Warnings

There are 20 known major drug interactions with Hetlioz.

Common Hetlioz Drug Interactions

Drug Name

Risk Level

Description

Azelastine

Major

Tasimelteon may increase the central nervous system depressant (CNS depressant) activities of Azelastine.

Deutetrabenazine

Major

The risk or severity of sedation and somnolence can be increased when Tasimelteon is combined with Deutetrabenazine.

Ethanol

Major

Tasimelteon may increase the central nervous system depressant (CNS depressant) activities of Ethanol.

Oliceridine

Major

The risk or severity of hypotension, sedation, death, somnolence, and respiratory depression can be increased when Tasimelteon is combined with Oliceridine.

Sodium oxybate

Major

Tasimelteon may increase the central nervous system depressant (CNS depressant) activities of Sodium oxybate.

Hetlioz Toxicity & Overdose RiskCommon side effects of tasimelteon include headaches, increased liver enzymes, nightmares, and infections in the upper respiratory or urinary tract. It has not been proven safe to take during pregnancy, and studies on animals suggest that it might be toxic to unborn babies. Additionally, rats did not try to seek out the drug during tests, meaning it is unlikely to be addictive.

Hetlioz Novel Uses: Which Conditions Have a Clinical Trial Featuring Hetlioz?

An ongoing research trial is assessing the potential of Hetlioz to reduce the symptoms of Non 24 Hour Sleep Wake Disorder.

Condition

Clinical Trials

Trial Phases

Sleep Disorders, Circadian Rhythm

0 Actively Recruiting

Smith-Magenis Syndrome

1 Actively Recruiting

Not Applicable

Insomnia

3 Actively Recruiting

Not Applicable

Patient Q&A Section about hetlioz

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is HETLIOZ a controlled substance?

"Unlike many other sleep aids, tasimelteon is not a controlled substance under the Controlled Substances Act."

Answered by AI

What is HETLIOZ used for?

"HETLIOZ® should be taken before bedtime.

The capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder (Non-24) in adults and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) patients 16 years of age and older."

Answered by AI

Is HETLIOZ a melatonin?

"Hetlioz (tasimelteon) is a drug that acts in a similar way to the natural hormone melatonin. Melatonin is produced by the body when it is dark out and helps to regulate the sleep cycle. The specific way in which Hetlioz works is not currently known."

Answered by AI

How do you take HETLIOZ?

"Your doctor may recommend that you take HETLIOZ® once a day, before bedtime. Make sure to swallow HETLIOZ® whole and take it without food. HETLIOZ® may cause drowsiness, so after taking it limit your activity to preparing for bed."

Answered by AI