☆ 4.3 Review

Daridorexant: Comprehensive Review of A New Oral Agent for the Treatment of Insomnia

ANNALS OF PHARMACOTHERAPY (2023)

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Article Clinical Neurology

Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials

Emmanuel Mignot et al.

Summary: This study assessed the safety and efficacy of daridorexant, a novel orexin receptor antagonist, in improving nighttime and daytime symptoms of insomnia. The results showed that daridorexant improved sleep outcomes and daytime functioning, with a favorable safety profile.

LANCET NEUROLOGY (2022)

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Review Clinical Neurology

The efficacy and safety of dual orexin receptor antagonists in primary insomnia: A systematic review and network meta-analysis

Tao Xue et al.

Summary: Multiple large randomized controlled trials have confirmed the efficacy and safety of dual orexin receptor antagonists (DORAs) for primary insomnia. Although there have been few systematic comparisons of different DORAs, it is generally believed that DORAs are superior to placebos in terms of efficacy and safety.

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Article Pharmacology & Pharmacy

Effect of gastric pH and of a moderate CYP3A4 inducer on the pharmacokinetics of daridorexant, a dual orexin receptor antagonist

Martine Gehin et al.

Summary: Daridorexant is a dual orexin receptor antagonist developed for insomnia treatment, with pH-dependent solubility and sensitivity to CYP3A4 inhibitors. Increasing gastric pH reduced C-max while co-administration with a CYP3A4 inducer decreased multiple pharmacokinetic parameters, indicating potential drug interaction. Overall, daridorexant showed good tolerability in the study.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2022)

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Article Pharmacology & Pharmacy

Driving Performance after Bedtime Administration of Daridorexant, Assessed in a Sensitive Simulator

Clemens Muehlan et al.

Summary: This study examined the effects of daridorexant on driving performance and found that it impaired simulated driving after initial dosing, but not after repeated dosing, in non-insomnia subjects. Users should exercise caution when driving after taking this medication.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2022)

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Article Pharmacology & Pharmacy

Daridorexant: First Approval

Anthony Markham

Summary: Daridorexant, an orally administered dual orexin receptor antagonist, has been approved in the USA for the treatment of insomnia based on the results of pivotal phase III trials.

DRUGS (2022)

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Article Clinical Neurology

Abuse potential assessment of the new dual orexin receptor antagonist daridorexant in recreational sedative drug users as compared to suvorexant and zolpidem

Mike Ufer et al.

Summary: This study evaluated the abuse potential of daridorexant in healthy recreational sedative drug users. The results showed dose-related drug-liking effects of daridorexant, with lower effects at the highest dose and similar effects at higher doses compared to supratherapeutic doses of suvorexant and zolpidem. The safety and pharmacokinetics of daridorexant were consistent with earlier trials, with quick absorption and elimination.

SLEEP (2022)

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Review Psychiatry

Orexin Receptor Antagonists and Insomnia

Xin Wu et al.

Summary: This review examines the use of orexin receptor antagonists (ORAs) in treating insomnia. Recent research focuses on comorbid insomnia with suvorexant, while lemborexant and daridorexant are still being studied for primary insomnia. Almorexant is mainly used in animal studies due to safety concerns. There is limited research on the sleep-promoting effects of filorexant. Seltorexant, a selective ORA, has not reached phase 3 yet. High-quality clinical trials are needed to compare authorized ORAs, investigate non-approved ORAs, and explore the pathophysiology of the orexin signaling system in insomnia.

CURRENT PSYCHIATRY REPORTS (2022)

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Article Geriatrics & Gerontology

Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial

Ingo Fietze et al.

Summary: In older patients with insomnia, as in younger patients, the efficacy of daridorexant is maximal at the higher dose of 50 mg on both nighttime and daytime variables. Older patients particularly require this dose to improve daytime functioning without an increased risk of adverse events or residual effects the next morning. The dose of daridorexant does not need to be decreased for older patients.

DRUGS & AGING (2022)

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Review Pharmacology & Pharmacy

Daridorexant for the treatment of insomnia disorder: findings and implications

Jessica Barreto Ribeiro dos Santos et al.

Summary: Daridorexant is an effective and safe medication for the treatment of insomnia disorder. Further studies are needed to evaluate its long-term safety and compare it with other medications.

EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY (2022)

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Article Clinical Neurology

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

Marie-Laure Boof et al.

Summary: The study showed that 50 mg daridorexant does not impair night-time respiratory function in patients with moderate COPD and actually improves sleep quality.

JOURNAL OF SLEEP RESEARCH (2021)

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Article Clinical Neurology

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

Benjamin Berger et al.

Summary: The study investigated the pharmacokinetic and pharmacodynamic interactions between daridorexant and citalopram in healthy subjects, showing no relevant effects on exposure levels between the two drugs. Co-administration with citalopram at steady state led to changes in pharmacodynamic assessments, while doses up to 50 mg of daridorexant were found to be safe when used concomitantly with citalopram.

EUROPEAN NEUROPSYCHOPHARMACOLOGY (2021)

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Article Clinical Neurology

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

Marie-Laure Boof et al.

Summary: The study found that daridorexant did not have a negative impact on nighttime respiratory function in patients with mild and moderate obstructive sleep apnea, and instead showed a positive effect on improving sleep quality.

SLEEP (2021)

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Article Pharmacology & Pharmacy

Effect of Liver Cirrhosis on the Pharmacokinetics, Metabolism, and Tolerability of Daridorexant, A Novel Dual Orexin Receptor Antagonist

Benjamin Berger et al.

Summary: The study evaluated the impact of hepatic impairment on the metabolism and tolerability of daridorexant, finding that moderate liver cirrhosis causes impaired hepatic clearance of unbound daridorexant, prolonging the half-life.

CLINICAL PHARMACOKINETICS (2021)

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Impact of Daridorexant, a Dual Orexin Receptor Antagonist, on Cardiac Repolarization Following Bedtime Dosing: Results from a Thorough QT Study Using Concentration-QT Analysis

Uta Schilling et al.

Summary: The study showed that daridorexant does not affect cardiac repolarization at therapeutic and supratherapeutic doses, as evidenced by the absence of relevant QT prolongation.

CLINICAL DRUG INVESTIGATION (2021)

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Article Geriatrics & Gerontology

Insomnia Behavioral Treatment in the Elderly

Matthew R. Ebben

CLINICS IN GERIATRIC MEDICINE (2021)

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Article Medicine, Research & Experimental

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

Benjamin Berger et al.

Summary: This study evaluated the impact of renal impairment on the pharmacokinetics, safety, and tolerability of daridorexant, showing that the effects of daridorexant on patients with severe renal impairment are not considered clinically relevant and no dose adjustment is necessary for these patients.

CTS-CLINICAL AND TRANSLATIONAL SCIENCE (2021)

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Review Neurosciences

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

Catherine Roch et al.

Summary: Dual orexin receptor antagonists (DORAs), such as daridorexant, offer a novel type of sleep medication with benefits in insomnia treatment and improvement in daytime functioning, without the risk of tolerance or physical dependence. This new DORA inhibits the wake-promoting orexin neuropeptides specifically, avoiding widespread inhibition of neuronal pathways and associated side effects typical of positive allosteric GABA-A receptor modulators.

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JOURNAL OF PSYCHOPHARMACOLOGY (2020)

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Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder

Yves Dauvilliers et al.

ANNALS OF NEUROLOGY (2020)

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

Gary Zammit et al.

NEUROLOGY (2020)

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The dual orexin receptor antagonist daridorexant does not affect the pharmacokinetics of the BCRP substrate rosuvastatin

Isabelle Zenklusen et al.

CLINICAL AND EXPERIMENTAL PHARMACOLOGY AND PHYSIOLOGY (2020)

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Clinical pharmacology, efficacy, and safety of orexin receptor antagonists for the treatment of insomnia disorders

Clemens Muehlan et al.

EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY (2020)

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Article Clinical Neurology

Pharmacological Interactions between the Dual Orexin Receptor Antagonist Daridorexant and Ethanol in a Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Four-Way Crossover Phase I Study in Healthy Subjects

Benjamin Berger et al.

CNS DRUGS (2020)

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Interaction potential of the dual orexin receptor antagonist ACT-541468 with CYP3A4 and food: results from two interaction studies

Marie-Laure Boof et al.

EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY (2019)

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Review Clinical Neurology

Insomnia in the Elderly: A Review

Dhaval Patel et al.

JOURNAL OF CLINICAL SLEEP MEDICINE (2018)

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