Effects of tasimelteon: A Synthesis of Findings from 22 Studies

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Original Abstract of the Article

Main Research Findings

Tasimelteon is a melatonin agonist that has shown promise in treating Non-24-hour sleep-wake disorder (Non-24), a circadian rhythm disorder common in totally blind individuals. 15 . Non-24 occurs when the body's internal clock, responsible for regulating sleep-wake cycles, loses its synchronization with the 24-hour day. 15 . This leads to a pattern of excessive daytime sleepiness and nighttime insomnia. 15 . Tasimelteon works by acting on melatonin receptors to help reset the body's internal clock, improving sleep quality and daytime alertness. 15

In clinical trials, tasimelteon has demonstrated effectiveness in entraining the circadian pacemaker and maintaining entrainment in totally blind individuals with Non-24. 19 , 21 . Tasimelteon has also been shown to improve sleep-wake parameters and overall functioning in these patients. 19 . Importantly, tasimelteon has been generally well-tolerated in patients with Non-24. 19 .

The development of tasimelteon illustrates the modern approach to drug development, focusing on specific targets while minimizing potential off-target effects. 13 . This selectivity translates to a reduced risk of side effects and better safety profiles for patients. 13 .

Benefits and Risks

Benefits Summary

Tasimelteon has demonstrated effectiveness in entraining the circadian pacemaker and maintaining entrainment in totally blind individuals with Non-24. 19 , 21 . Tasimelteon has also been shown to improve sleep-wake parameters and overall functioning in these patients. 19 . Its targeted action on melatonin receptors with limited impact on other receptors or enzymes contributes to a lower risk of side effects and a favorable safety profile. 13 .

Risks Summary

While generally well-tolerated, tasimelteon may cause some side effects such as headache, drowsiness, and gastrointestinal issues. 22 . It is important to discuss any potential interactions with other medications with a healthcare provider before starting tasimelteon. 13 .

Comparison Across Studies

Commonalities

Multiple studies consistently demonstrate the efficacy of tasimelteon in treating Non-24 in totally blind individuals, improving circadian rhythm synchronization and overall sleep quality. 19 , 21 .

Differences

Research findings can vary in terms of tasimelteon dosage, timing of administration, and the specific extent of observed benefits. 19 , 21 .

Consistency and Contradictions in Findings

The evidence consistently points towards the effectiveness of tasimelteon in treating Non-24. 19 , 21 . However, individual responses to the medication may vary. 21 .

Implications for Real-life Application

Tasimelteon should be used under the guidance of a healthcare provider. It's important to discuss any potential drug interactions and to be aware of potential side effects like drowsiness, which could impact activities like driving or operating machinery. 13 , 22 .

Current Limitations in Research

Further research is needed to understand the long-term effects and safety of tasimelteon. 22 . It's also essential to explore effective treatment options for patients who may not respond well to tasimelteon or experience significant side effects. 21 .

Future Research Directions

Ongoing research should focus on determining the long-term effects and safety of tasimelteon. 22 . Further research is also needed to develop alternative treatments for individuals who do not respond well to tasimelteon or experience adverse effects. 21 .

Conclusion

Tasimelteon has emerged as a promising treatment option for Non-24, a circadian rhythm disorder prevalent in totally blind individuals. 19 , 21 . It effectively synchronizes the internal clock, leading to improved sleep quality and daytime alertness. However, individual responses may vary, and further research is needed to fully understand its long-term implications and address those who may not respond well to the medication. 21 . It is crucial to use tasimelteon under medical supervision to manage potential interactions and side effects. 13 , 22 .

Literature analysis of 22 papers
Positive Content
21
Neutral Content
1
Negative Content
0
Article Type
5
3
3
10
22
1.

A randomised, placebo-controlled trial comparing the effects of tapentadol and oxycodone on gastrointestinal and colonic transit in healthy humans.

Author: JeongI D, CamilleriM, ShinA, IturrinoJ, BoldinghA, BusciglioI, BurtonD, RyksM, RhotenD, ZinsmeisterA R

Pain relief
GI side effects

This study investigates the effects of tapentadol, a mu-opioid receptor agonist and norepinephrine reuptake inhibitor, on gastrointestinal and colonic transit. The study aims to understand the impact of tapentadol on digestion and bowel movements.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

[Undesired side effects of tapentadol in comparison to oxycodone. A meta-analysis of randomized controlled comparative studies].

Author: MerkerM, DingesG, KochT, KrankeP, MorinA M

Less GI side effects
Pain relief

This study reviewed randomized controlled trials comparing tapentadol and oxycodone for pain management. The objective was to evaluate the relative amount of adverse effects associated with each drug.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : German

3.

Miotic and subject-rated effects of therapeutic doses of tapentadol, tramadol, and hydromorphone in occasional opioid users.

Author: StoopsWilliam W, GlaserPaul E A, RushCraig R

Tapentadol analgesia
Tramadol side effects

Tapentadol, a novel analgesic, produced a profile of positive effects comparable to hydromorphone. Tramadol, another analgesic, produced both positive and negative subject-rated effects.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Tapentadol versus oxycodone analgesia and side effects after laparoscopic hysterectomy: A randomised controlled trial.

Author: ComelonMarlin, RaederJohan, DrægniTomas, LiengMarit, LenzHarald

Reduced side effects
Synergistic analgesia

Tapentadol, an opioid with a dual mechanism of action, was investigated for its effectiveness in postoperative pain management.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Tapentadol results in less deterioration of gastrointestinal function and symptoms than standard opioid therapy in healthy male volunteers.

Author: MarkEsben Bolvig, NedergaardRasmus Bach, HansenTine Maria, NissenThomas Dahl, FrøkjaerJens Brøndum, ScottS Mark, KroghKlaus, DrewesAsbjørn Mohr

Improved pain management
Reduced GI side effects

This study aims to investigate the effects of tapentadol and oxycodone on gastrointestinal motility and side effects, focusing on a more precise assessment of mechanistic effects and comparisons with other opioids or placebo.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

The Involvement of Melatonin and Tasimelteon against Alzheimer's Disease.

Author: RavikumarMrinalini, MohanSumithra, VelpandianChitra

Improved sleep
Reduced neurotoxicity

Melatonin and its analogue tasimelteon may offer therapeutic value in treating Alzheimer's disease by addressing sleep disruption and neuroinflammation, both of which contribute to Alzheimer's pathology.

ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Antidepressant actions of melatonin and melatonin receptor agonist: Focus on pathophysiology and treatment.

Author: WangYe-Qing, JiangYa-Jie, ZouMan-Shu, LiuJian, ZhaoHong-Qing, WangYu-Hong

Antidepressant effects
Unknown

Melatonin, a hormone regulating circadian rhythm, has shown antidepressant effects through multiple mechanisms including regulation of the hypothalamic-pituitary-adrenal axis, inhibition of neuroinflammation, and promotion of neuroplasticity. Melatonin receptor agonists are also promising therapeutic agents for depression.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

11.

Prophylactic use of exogenous melatonin and melatonin receptor agonists to improve sleep and delirium in the intensive care units: a systematic review and meta-analysis of randomized controlled trials.

Author: ZhangQingyu, GaoFuqiang, ZhangShuai, SunWei, LiZirong

Delirium treatment
Reduced ICU stay
Sleep improvement

This study investigates the efficacy of melatonin and melatonin receptor agonists in improving delirium, sleep quality, and other clinical outcomes in intensive care unit (ICU) patients. The study found that melatonin administration was associated with a trend towards longer sleep duration, fewer awakenings per night, a reduced prevalence of delirium, and a shorter duration of ICU stay.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

12.

Drugs for Insomnia beyond Benzodiazepines: Pharmacology, Clinical Applications, and Discovery.

Author: AtkinTobias, ComaiStefano, GobbiGabriella

Personalized insomnia treatment
BZD/Z-drug side effects

This review analyzes the neurobiological and clinical evidence of pharmacological treatments of insomnia, excluding the benzodiazepines (BZDs) and Z-drugs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

A Review of Suvorexant, Doxepin, Ramelteon, and Tasimelteon for the Treatment of Insomnia in Geriatric Patients.

Author: EdmondsChelsey, SwanoskiMichael

Insomnia treatment
Cognitive impairment
Falls
Fractures

Geriatric patients often experience insomnia. This paper explores and outlines the available safety and efficacy data associated with suvorexant, doxepin, ramelteon, and tasimelteon and reviews their potential place in therapy in treating insomnia in the geriatric population.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

Diagnosis and Treatment of Non-24-h Sleep-Wake Disorder in the Blind.

Author: EmensJonathan S, EastmanCharmane I

Non-24 sleep-wake disorder treatment

Non-24-hour sleep-wake disorder (non-24) is a circadian rhythm disorder affecting 55-70% of totally blind individuals. This review discusses the use of melatonin and tasimelteon for treating non-24, highlighting the importance of considering the individual's circadian period when determining the optimal administration time.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

A Review of Melatonin, Its Receptors and Drugs.

Author: EmetMucahit, OzcanHalil, OzelLutfu, YaylaMuhammed, HaliciZekai, HacimuftuogluAhmet

Anti-inflammatory effect
Antioxidant effect
Anxiolytic effect
Neuroprotective effect
Pain-modulating effect

Melatonin, a hormone secreted by the pineal gland, has various effects on the body, including regulation of the sleep-wake cycle, pubertal development, and seasonal adaptation. This review summarizes the potential benefits and risks of melatonin and its agonists, highlighting their therapeutic potential in various medical fields.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Comparative Review of Approved Melatonin Agonists for the Treatment of Circadian Rhythm Sleep-Wake Disorders.

Author: WilliamsWilbur P Trey, McLinDewey E, DressmanMarlene A, NeubauerDavid N

CRSWDs treatment

This review discusses the use of melatonin receptor agonists for the treatment of circadian rhythm sleep-wake disorders (CRSWDs). While only tasimelteon is currently approved for the treatment of non-24-hour sleep-wake disorder, other melatonin receptor agonists like agomelatine, prolonged-release melatonin, and ramelteon are being investigated for their potential use in treating other CRSWDs. This review summarizes the pharmacologic properties of these agonists and their efficacy in treating CRSWDs, emphasizing the need for further research to determine their full therapeutic potential.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

18.

Inflammaging, Metabolic Syndrome and Melatonin: A Call for Treatment Studies.

Author: CardinaliDaniel P, HardelandRüdiger

Antioxidant properties
Modulate immune system
Neuroprotective actions
Insulin resistance
Weight gain

Melatonin has multiple protective actions against the metabolic syndrome, including anti-inflammatory effects and modulation of the immune system.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

19.

Tasimelteon: A Review in Non-24-Hour Sleep-Wake Disorder in Totally Blind Individuals.

Author: KeatingGillian M

Entrainment of circadian pacemaker
Improved functioning
Improved sleep/wake parameters
Well tolerated

This study found that tasimelteon, a dual melatonin receptor agonist, was effective in treating Non-24-Hour Sleep-Wake Disorder in totally blind individuals. Tasimelteon significantly increased the likelihood of entraining and maintaining entrainment of the circadian pacemaker compared to placebo.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

MT1 and MT2 Melatonin Receptors: A Therapeutic Perspective.

Author: LiuJiabei, CloughShannon J, HutchinsonAnthony J, Adamah-BiassiEkue B, Popovska-GorevskiMarina, DubocovichMargarita L

cancer treatment
circadian rhythm regulation
drug abuse treatment
learning and memory enhancement
mood disorder treatment
neuroprotection
sleep improvement

This review describes the pharmacological properties of slow-release melatonin preparation (Circadin®) and synthetic ligands (agomelatine, ramelteon, tasimelteon), with emphasis on identifying specific therapeutic effects mediated through MT1 and MT2 receptor activation. The discovery of selective ligands targeting the MT1 or the MT2 melatonin receptors may promote the development of novel and more efficacious therapeutic agents for treating insomnia, circadian rhythms, mood disorders, and cancer.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

21.

Tasimelteon for non-24-hour sleep-wake disorder in totally blind people (SET and RESET): two multicentre, randomised, double-masked, placebo-controlled phase 3 trials.

Author: LockleySteven W, DressmanMarlene A, LicameleLouis, XiaoChangfu, FisherDennis M, Flynn-EvansErin E, HullJoseph T, TorresRosarelis, LavedanChristian, PolymeropoulosMihael H

Circadian rhythm treatment

This study investigated the safety and efficacy of tasimelteon, a novel dual-melatonin receptor agonist, in patients with non-24-hour sleep-wake disorder.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

22.

Safety profile of tasimelteon, a melatonin MT1 and MT2 receptor agonist: pooled safety analyses from six clinical studies.

Author: LegerDamien, Quera-SalvaMaria-Antonia, VecchieriniMarie-Françoise, OgrizekPascale, PerryChristina A, DressmanMarlene A

Non-24 treatment

Tasimelteon is a new medication that helps regulate the body's natural sleep-wake cycle. It is the first FDA-approved treatment for Non-24-hour Sleep-Wake Disorder, a condition where the body's natural sleep-wake cycle is out of sync with the 24-hour day. Tasimelteon is a melatonin receptor agonist that works by binding to the MT1 and MT2 receptors in the brain. It has a higher affinity for the MT2 receptor, which may be responsible for its effectiveness in treating Non-24.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.

Language : English

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