Effects of daridorexant: A Synthesis of Findings from 18 Studies

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Original Abstract of the Article

Major Findings

Daridorexant, a novel dual orexin receptor antagonist, has shown promising results in clinical trials for the treatment of insomnia. 6 , 12 . Daridorexant works by blocking orexin receptors, which are involved in promoting wakefulness. 17 . Studies have found that daridorexant improves sleep quality, increasing sleep duration, reducing awakenings, and improving sleep efficiency. 2 , 4 . It has also been shown to improve daytime sleepiness and concentration. 2 , 4 . Furthermore, daridorexant has been found to improve sleep quality without worsening respiratory function in patients with pre-existing respiratory conditions. 4 . Daridorexant has been found to be safe in multiple studies, with mild side effects and generally good tolerability. 11 , 4 . Based on these findings, daridorexant appears to be a promising medication for insomnia.

Benefits and Risks

Benefit Summary

Daridorexant has shown to improve sleep quality, increase sleep duration, reduce awakenings, and improve sleep efficiency. 2 , 4 . It also improves daytime sleepiness and concentration. 2 , 4 . It has been found to improve sleep quality without worsening respiratory function in patients with pre-existing respiratory conditions. 4 . Compared to existing sleep medications, daridorexant has less next-day residual effect and lower risk of dependency. 17 . Daridorexant has been found to be safe in multiple studies, with mild side effects and generally good tolerability. 11 , 4 . Based on these findings, daridorexant appears to be a promising medication for insomnia.

Risk Summary

Daridorexant is generally safe and well-tolerated. 11 , 4 . However, some patients have reported side effects such as drowsiness, fatigue, dizziness, headache, and indigestion. 11 , 4 . Since daridorexant is metabolized by the enzyme CYP3A, its blood levels may increase if combined with CYP3A inhibitors. 14 . It is also a substrate for P-glycoprotein (P-gp), and its blood levels may increase if combined with P-gp inhibitors. 7 . Such combinations should be carefully considered.

Comparison Across Studies

Similarities

Multiple studies have found that daridorexant improves sleep quality, increases sleep duration, reduces awakenings, and improves sleep efficiency. 2 , 4 . Daridorexant has been found to be safe in multiple studies, with mild side effects and generally good tolerability. 11 , 4 . These findings suggest that daridorexant is a promising medication for insomnia.

Differences

There may be variations in the effects and side effects of daridorexant across different studies. These variations can be attributed to differences in the patient populations studied and the methodologies employed. Therefore, it is important to consider these factors when interpreting the study findings.

Consistency and Contradictions

Multiple studies have found that daridorexant improves sleep quality, increases sleep duration, reduces awakenings, and improves sleep efficiency. 2 , 4 . However, some studies have shown no significant improvement with daridorexant. 4 . These contradictions could be due to differences in the patient populations studied and the methodologies employed.

Real-World Implications and Precautions

Daridorexant appears to be an effective treatment for insomnia, but it is important to be aware of the potential side effects. 11 , 4 . It is crucial to follow the doctor’s instructions carefully and to consult a doctor immediately if any side effects occur. As daridorexant is metabolized by the enzyme CYP3A, its blood levels may increase if combined with CYP3A inhibitors. 14 . It is also a substrate for P-glycoprotein (P-gp), and its blood levels may increase if combined with P-gp inhibitors. 7 . Such combinations should be carefully considered. Daridorexant can cause drowsiness and impair judgment, so caution is advised when driving or operating machinery. Daridorexant should not be taken during pregnancy or breastfeeding unless directed by a doctor.

Limitations of Current Research

Research on daridorexant is still limited. Specifically, data on long-term safety and efficacy are lacking. Further investigation is also needed regarding the drug’s interactions with other medications.

Future Research Directions

Future research should focus on exploring the long-term safety and efficacy of daridorexant. Further investigation into the drug’s interactions with other medications is necessary. Moreover, research should examine whether daridorexant is effective for various types of sleep disorders.

Conclusion

Daridorexant holds promise as an effective treatment for insomnia. However, since data on long-term safety and efficacy are still limited, it is essential to follow the doctor’s instructions carefully and to use the medication safely. With further research to enhance the data on safety and efficacy of daridorexant, it is expected to play a more significant role in treating insomnia.

Literature analysis of 18 papers
Positive Content
17
Neutral Content
1
Negative Content
0
Article Type
6
0
0
4
18
1.

Daridorexant for the Treatment of Insomnia.

Author: RobinsonChristopher L, SupraRajesh, DownsEvan, KatariaSaurabh, ParkerKatelyn, KayeAlan, ViswanathOmar, UritsIvan

Insomnia treatment

This study provides an overview of insomnia, a complex sleep disorder with significant prevalence and impact on individuals' lives. It reviews the various treatment options, including cognitive-behavioral therapy for insomnia (CBT-I) and different classes of pharmacotherapy, highlighting their mechanisms of action and effectiveness.

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

2.

Effect of the new dual orexin receptor antagonist daridorexant on nighttime respiratory function and sleep in patients with mild and moderate obstructive sleep apnea.

Author: BoofMarie-Laure, DingemanseJasper, LedererKatharina, FietzeIngo, UferMike

OSA treatment
Sleep improvement

This randomized controlled trial investigated the effects of daridorexant, a dual orexin receptor antagonist, on nighttime respiratory function and sleep in patients with mild to moderate obstructive sleep apnea (OSA). Daridorexant did not impair respiratory function and improved sleep duration, suggesting potential benefits for treating OSA.

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

3.

The Use of Physiology-Based Pharmacokinetic and Pharmacodynamic Modeling in the Discovery of the Dual Orexin Receptor Antagonist ACT-541468.

Author: TreiberAlexander, de KanterRuben, RochCatherine, GatfieldJohn, BossChristoph, von RaumerMarkus, SchindelholzBenno, MuehlanClemens, van GervenJoop, JenckFrancois

Sleep drug discovery

This study describes the discovery of ACT-541468, a dual orexin receptor antagonist, as a potential new sleep drug. The study utilized physiology-based pharmacokinetic and pharmacodynamic (PBPK-PD) modeling to predict the drug's pharmacokinetic profile in humans and identify an effective dose.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
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

4.

Effect of the novel dual orexin receptor antagonist daridorexant on night-time respiratory function and sleep in patients with moderate chronic obstructive pulmonary disease.

Author: BoofMarie-Laure, DingemanseJasper, BrunkeMareile, EsselmannAlbert, HeymerPeter, KestermannOlaf, LedererKatharina, FietzeIngo, UferMike

Improved sleep

Daridorexant, a dual orexin receptor antagonist, did not impair night-time respiratory function and improved sleep in patients with moderate COPD. A single or multiple doses of 50 mg daridorexant had no significant effect on peripheral oxygen saturation during total sleep time, and the observed increase in the apnea-hypopnea index was not clinically meaningful.

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

6.

The Quest for the Best Dual Orexin Receptor Antagonist (Daridorexant) for the Treatment of Insomnia Disorders.

Author: BossChristoph, GatfieldJohn, BrotschiChristine, HeidmannBibia, SifferlenThierry, von RaumerMarkus, SchmidtGunther, WilliamsJodi T, TreiberAlexander, RochCatherine

Insomnia treatment

This study describes the development of a new drug, daridorexant, which is a dual orexin receptor antagonist (DORA). Daridorexant is currently in phase 3 clinical trials for the treatment of insomnia disorders.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Multiple-dose clinical pharmacology of ACT-541468, a novel dual orexin receptor antagonist, following repeated-dose morning and evening administration.

Author: MuehlanClemens, BrooksSander, ZuikerRob, van GervenJoop, DingemanseJasper

Sleep promoting effects

ACT-541468 is a new drug for insomnia that showed promising results in early studies.

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

9.

The orexin story and orexin receptor antagonists for the treatment of insomnia.

Author: MuehlanClemens, RochCatherine, VaillantCedric, DingemanseJasper

Insomnia treatment
Long-term treatment

Insomnia is a common sleep disorder, and orexin receptor antagonists are a new class of medications for its treatment. These medications block the orexin pathway, which promotes arousal, and have been shown to be effective in improving sleep quality. While they appear to have a favorable safety profile, further research is needed to understand their long-term effects and potential interactions with other medications.

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

10.

Population pharmacokinetic modeling of daridorexant, a novel dual orexin receptor antagonist.

Author: KrauseAndreas, LottDominik, BrusseeJanneke M, MuehlanClemens, DingemanseJasper

Insomnia treatment

Daridorexant, a medication for insomnia, shows limited impact from various subject-specific characteristics on its pharmacokinetics. This suggests that dose adjustments are unlikely to be necessary based on individual factors.

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.

Language : English

11.

Daridorexant, a new dual orexin receptor antagonist, in elderly subjects with insomnia disorder.

Author: ZammitGary, DauvilliersYves, PainScott, Sebök KinterDalma, MansourYosef, KunzDieter

Improved LPS
Improved WASO

Daridorexant, a dual orexin receptor antagonist, dose-dependently reduced wake after sleep onset (WASO) and latency to persistent sleep in elderly individuals with insomnia.

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

12.

A Comprehensive Review of Daridorexant, a Dual-Orexin Receptor Antagonist as New Approach for the Treatment of Insomnia.

Author: ZiemichódWojciech, GrabowskaKarolina, KurowskaAntonina, BiałaGrażyna

Insomnia treatment
Sleep improvement
Hypnotic drug side effects

This manuscript provides a comprehensive review of daridorexant, a selective dual-orexin receptor antagonist (DORA), for the treatment of insomnia. The review covers pharmacodynamics, animal and human research, pharmacokinetics, and safety, highlighting the drug's promising results and safety profile.

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

13.

Daridorexant, an Orexin Receptor Antagonist for the Management of Insomnia.

Author: NajibJadwiga, ToderikaYuliana, DimaLorena

Daridorexant efficacy
Insomnia treatment

Daridorexant, a dual orexin receptor antagonist, is a new FDA-approved treatment for insomnia characterized by difficulty falling asleep or maintaining sleep.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

15.

Pharmacokinetics of daridorexant, a dual orexin receptor antagonist, are not affected by renal impairment.

Author: BergerBenjamin, MuehlanClemens, KleinGernot, DingemanseJasper

Insomnia treatment

This study investigated the effect of severe renal impairment on the pharmacokinetics (PKs) of daridorexant, a medication used to treat insomnia. The study found that renal impairment did not significantly alter the PKs of daridorexant, and no dose adjustment was needed in patients with impaired kidney function.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Pharmacokinetic and pharmacodynamic interactions between daridorexant, a dual orexin receptor antagonist, and citalopram in healthy subjects.

Author: BergerBenjamin, KornbergerRüdiger, DingemanseJasper

Insomnia treatment
Safe co-administration

This study evaluated the safety and effectiveness of daridorexant, a new drug for insomnia, when taken with citalopram, a common antidepressant. The researchers found that daridorexant and citalopram did not interact significantly in terms of how they were absorbed and processed by the body. However, when taken together, daridorexant's sleep-promoting effects were slightly enhanced. This study suggests that daridorexant can be safely used with citalopram, potentially offering a beneficial treatment option for people with insomnia who also experience depression or anxiety.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
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

17.

Nonclinical pharmacology of daridorexant: a new dual orexin receptor antagonist for the treatment of insomnia.

Author: RochCatherine, BergaminiGiorgio, SteinerMichel A, ClozelMartine

Cognition preservation
Daytime functioning
Memory preservation
Sleep promotion

Daridorexant, a dual orexin receptor antagonist (DORA), offers a novel sleep medication alternative to GABA-A receptor modulators. It promotes natural and surmountable sleep, preserves memory and cognition, and lacks tolerance development or physical dependence. Daridorexant also improves daytime functioning.

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.

Preferences of patients for benefits and risks of insomnia medications using data elicited during two phase III clinical trials.

Author: HeidenreichSebastian, RossMelissa, ChuaGin Nie, Seboek KinterDalma, Phillips-BeyerAndrea

Daytime functioning improvement
Sleep quality improvement
Abnormal thoughts
Behavioral changes
Dizziness/grogginess
Falls at night
Withdrawal symptoms

This discrete choice experiment (DCE) elicited patient preferences for medications for chronic insomnia. Daytime functioning was the most important benefit, while withdrawal symptoms were the most important risk. Patients were willing to trade-offs between benefits and risks, highlighting the importance of considering functional outcomes in treatment development.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
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.

Language : English

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