What side effects are associated with this type of intervention?

Common treatments for chronobiology disorders, such as melatonin and melatonin receptor agonists like Tasimelteon, generally have a favorable safety profile but can cause some side effects. Melatonin is typically well-tolerated, with potential side effects including dizziness, daytime drowsiness, and headaches. Tasimelteon, another melatonin receptor agonist, may cause headaches, elevated liver enzymes, and nightmares. Light therapy, another common treatment, can lead to eye strain, headaches, and nausea. It is important for patients to discuss these potential side effects with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for chronobiology disorders, particularly focusing on melatonin and melatonin receptor agonists. Melatonin itself is widely used for various sleep-wake disorders, including Delayed Sleep-Wake Phase Disorder (DSWPD). Another notable FDA-approved drug is Ramelteon, a melatonin receptor agonist similar to Tasimelteon, which is used for the treatment of insomnia characterized by difficulty with sleep onset. These treatments work by targeting the body's circadian rhythms to promote better alignment of sleep-wake cycles.

What other types of research exist?

Promising alternatives to Tasimelteon for chronobiology disorders include melatonin and agomelatine. Both have shown efficacy in managing sleep-related issues and circadian rhythm disorders.

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Tasimelteon for Delayed Sleep-Wake Phase Disorder

Phase 3

Recruiting

Research Sponsored by Vanda Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial tests a pill called tasimelteon in people who have trouble falling asleep and waking up at normal times. The goal is to see if tasimelteon can help reset their sleep schedule. Both men and women with this sleep disorder are included in the study.

Who is the study for?

This trial is for men and women aged 18-75 with a confirmed diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD). Participants must have a BMI between 18 and 35, be able to consent, and not have had psychiatric disorders in the past year. Pregnant or breastfeeding women, recent surgery patients, or those who've been immobile for extended periods cannot join.

What is being tested?

The study compares the effects of Tasimelteon—a medication—against a placebo in treating DSWPD. It's conducted across multiple centers where participants are randomly assigned to receive either Tasimelteon or an inactive pill without knowing which one they're getting.

What are the potential side effects?

While specific side effects aren't listed here, clinical trials like this often monitor for any adverse reactions ranging from mild discomforts such as headaches or nausea to more serious conditions that could affect sleep patterns, mood, or physical health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 3 trial • 320 Patients • NCT03373201

Headache

Atrial Fibrillation

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Tasimelteon

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TasimelteonExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tasimelteon

2016

Completed Phase 3

~540

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronobiology Disorders, such as melatonin receptor agonists (e.g., Tasimelteon) and melatonin supplementation, work by targeting the body's circadian rhythm. Melatonin receptor agonists bind to melatonin receptors in the brain, mimicking the natural hormone's effects to help regulate sleep-wake cycles. Melatonin supplements increase the levels of melatonin in the body, promoting sleep onset and adjusting the circadian phase. Light therapy, another common treatment, involves exposure to bright light at specific times to shift the circadian rhythm. These treatments are crucial for patients with Chronobiology Disorders as they help synchronize their internal clock with the external environment, improving sleep quality and overall functioning.

Treatment of a patient with a circadian sleep-wake disorder using a combination of melatonin and metoprolol.