eszopiclone / Generic mfg. - LARVOL DELTA

Lemborexant overdose presenting with mild sedation despite high plasma levels: A case report. (PubMed, Toxicol Rep) - "A 33-year-old woman presented to the emergency department four hours after ingesting an estimated 720 mg of lemborexant and 78 mg of eszopiclone. This case suggests that massive lemborexant overdoses may not cause life-threatening toxicity even when plasma levels approach those reported in fatal cases. This case provides preliminary but clinically important data and highlights the need for further research to better characterize the clinical implications and management of lemborexant overdoses."

Journal • Anesthesia • CNS Disorders • Depression • Insomnia • Psychiatry • Sleep Disorder

Sini-Suanzaoren decoction regulates mitochondrial biogenesis mediated by MT-SIRT1 in the treatment of insomnia rats. (PubMed, World J Psychiatry) - "SNSZRD might exert its therapeutic effects on insomnia by modulating MT-SIRT1 axis-regulated mitochondrial biogenesis in rats and might serve as an effective therapeutic agent for insomnia."

Journal • Preclinical • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder • NRF1 • PPARG • SIRT1

NAP: National Adaptive Trial for PTSD Related Insomnia (clinicaltrials.gov) - P3 | N=673 | Active, not recruiting | Sponsor: VA Office of Research and Development | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Insomnia • Post-traumatic Stress Disorder • Sleep Disorder

Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP) (clinicaltrials.gov) - P2 | N=42 | Completed | Sponsor: University of California, San Diego | Recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Oct 2025

Trial completion • Trial completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Efficacy of Eszopiclone Plus Acupuncture Therapy by Dispersing the Stagnated Liver-Qi and Regulating the Spirit for Treating Chronic Fatigue Syndrome-Related Sleep Disorders. (PubMed, Psychiatry Clin Psychopharmacol) - "Safety profiles favored the observation group, with fewer adverse reactions reported (7.02% vs 22.00%) (P=.026). Eszopiclone plus the acupuncture therapy enhances the efficacy of treating CFS-induced sleep disorders, effectively improves serum 5-HT and BDNF levels in patients, and reduces adverse reactions."

Journal • CNS Disorders • Fatigue • Infectious Disease • Sleep Disorder • BDNF

Effects of Shallow Needling for Chronic Primary Insomnia: Protocol for a Randomized Controlled Trial. (PubMed, JMIR Res Protoc) - "The control group will receive 1 mg eszopiclone orally, once a day for 4 weeks...This study will evaluate the therapeutic effectiveness and safety of shallow needling in the treatment of chronic insomnia to provide the necessary scientific basis for the clinical application and promotion of shallow needling. The findings of this study may provide a scientific and standardized treatment protocol for shallow needling in adults with chronic insomnia."

Clinical • Journal • CNS Disorders • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder

Too tired to learn: insomnia, sleep quality, and sleep aid practices among Kasr Al Ainy medical students: a cross-sectional analysis. (PubMed, BMC Med Educ) - "This study reveals the burden of sleep disturbance among medical students, with a major gap between the prevalence of insomnia and the utilization of professional sleep interventions. The off-label use of quetiapine, even among a small subset of our sample, raises notable safety concerns. This finding serves as an important pharmacovigilance signal and underscores the need for further investigation into the risks associated with this potentially hazardous practice. Non-pharmacological strategies such as sleep hygiene education and cognitive-behavioral interventions are needed."

Journal • CNS Disorders • Infectious Disease • Insomnia • Psychiatry • Sleep Disorder

Z-drug abuse and dependence: clinical guideline of the Brazilian Academy of Neurology for diagnosis and management. (PubMed, Arq Neuropsiquiatr) - "An advisory committee, consisting of neurologists from the Brazilian Academy of Neurology (Academia Brasileira de Neurologia, ABN, in Portuguese) and psychiatrists specializing in substance-use disorders, contributed to the selection and organization of the scientific literature and took part in the voting process. Key recommendations were established: 1) prior to discontinuation, a comprehensive assessment of mental status, psychiatric and sleep comorbidities, and the degree of pharmacological dependence is essential; 2) gradual tapering is advised; 3) non-pharmacological interventions, such as cognitive behavioral therapy for insomnia, are recommended, and acceptance and commitment therapy, which is optional, may be incorporated; 4) for zolpidem withdrawal, adjunctive pharmacotherapy, which is optional, may include trazodone, other antidepressants, quetiapine or other antipsychotics, alpha-2-delta (α2δ) ligands, or alternative hypnotics (such as ramelteon, zopiclone,..."

Clinical guideline • Journal • Review • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder

A Randomized, Open-Label, Positive-Controlled Study on the Efficacy and Safety of Daridorexant, a GABA-A Receptor Partial Agonist, in the Treatment of Patients with Recurrent Depression Complicated by Insomnia (ChiCTR) - P4 | N=80 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University

New P4 trial • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder

Efficacy and safety of insomnia pharmacotherapies: Convergent evidence from Bayesian network meta-regression and FAERS-based disproportionality analysis. (PubMed, Sleep Med) - "Comprehensively considering the efficacy effect size, time windows (follow-up period, age, and types of insomnia), PV, severity of imperative adverse events, we propose prioritizing the use of daridorexant 25 mg/d for insomnia characterized by difficulty maintaining sleep and insufficient sleep duration. For insomnia characterized by difficulty falling asleep, we recommend prioritizing the use of lemborexant 10 mg/day or zolpidem 10 mg/day. For overall poor sleep efficiency, we recommend using lemborexant. Drug selection should be based on the types of insomnia and drug safety. More head-to-head clinical trials are needed to confirm those findings."

Journal • Review • CNS Disorders • Insomnia • Pulmonary Disease • Sleep Disorder

Tiaowei Jiannao acupuncture for post-ischemic stroke insomnia: a randomized controlled trial (PubMed, Zhongguo Zhen Jiu) - "In the medication group, eszopiclone tablet was given orally, 1-3 mg a time, once a day for 3 weeks...Tiaowei Jiannao acupuncture improves the insomnia symptoms in patients with ischemic stroke, improves the quality of sleep, increases the deep sleep, promotes the recovery of neurological function, and relieves the depression. It is effective and safe for the treatment of PISI."

Clinical • Journal • Cardiovascular • CNS Disorders • Depression • Insomnia • Ischemic stroke • Psychiatry • Sleep Disorder

Efficacy and acceptability of pharmacological interventions for insomnia in patients with severe mental illness: A systematic review and meta-analysis (ECNP 2025) - "The most frequently studied drugs were agomelatine (RCTs=3, n=686), eszopiclone (RCTs=3, n=599), and zolpidem (RCTs=3, n=601). Despite their frequent use, many pharmacological interventions for insomnia have never been investigated in patients with SMI. The studies that provided sufficient data for meta-analysis showed better efficacy with similar acceptability compared to placebo, but the generalizability of these results is limited by the high heterogeneity and low quality of the included studies. This underscores the need for high-quality RCTs to provide a better scientific basis for the pharmacological treatment of insomnia in SMI."

Retrospective data • Review • Bipolar Disorder • CNS Disorders • Depression • Insomnia • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia • Sleep Disorder

Pharmacotherapy for obstructive sleep apnea: a critical review of randomized placebo-controlled trials. (PubMed, Sleep Med Rev) - "Weight-loss agents, particularly tirzepatide, represent a promising and now clinically viable treatment option. While endotype-targeted approaches are conceptually attractive, many agents were too early in their testing/re-purposing phase to demonstrate improvements in sleepiness, quality of life or sustained reductions of OSA severity; or were insufficiently targeted at the endotype they might best treat."

Journal • Review • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Effect of Lemborexant-Based Sleep Medication Formulary on Benzodiazepine Reduction and Clinical Outcomes: A Single-Center Retrospective Study. (PubMed, Neuropsychopharmacol Rep) - "Following implementation, prescription volumes of lemborexant and eszopiclone increased significantly, whereas diazepam equivalents decreased from 10 682 mg to 4117 mg. The median hospital stay also decreased from 8 to 7 days. These findings suggest that formulary implementation effectively optimized hypnotic prescribing and contributed to improved clinical outcomes and patient safety in an acute care setting."

Clinical data • Journal • Retrospective data • CNS Disorders • Psychiatry

Efficacy and Acceptability of Licensed and Off-Label Pharmacological Interventions for Insomnia in Patients With Severe Mental Illness: A Systematic Review and Meta-Analysis of Randomised Trials. (PubMed, Acta Psychiatr Scand) - "Despite their frequent use, many licensed and off-label pharmacological interventions for insomnia have never been investigated in patients with SMI. The studies that provided sufficient data for meta-analysis showed better efficacy with similar acceptability compared to placebo, but the generalizability of these results is limited by the high heterogeneity and low quality of the included studies. This underscores the need for high-quality RCTs to provide a better scientific basis for the pharmacological treatment of insomnia in SMI."

Journal • Retrospective data • Review • Bipolar Disorder • CNS Disorders • Depression • Insomnia • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia • Sleep Disorder

Real-World Treatment Patterns of Sleep Medications in the United States Veterans Affairs Health System (WSS 2025) - "Overall, an estimated 2.6% were prescribed zolpidem, 0.7% temazepam, 0.28% eszopiclone, 0.12% ramelteon, 0.6% zaleplon, 0.5% suvorexant, 0.4% triazolam, 0.006 lemborexant, 0.005% estazolam, and 0.0001% daridorexant. The Z-drug zolpidem was the most commonly prescribed medication indicated for insomnia. Sedative antidepressants were also frequently utilized, likely due to their affordability and the lack of widely accepted, cost-effective alternatives for managing insomnia. This reliance on off-label agents such as trazodone suggests a potential gap between clinical guidelines and real-world practice, possibly reflecting formulary constraints, prescriber familiarity, or patient comorbidities."

Clinical • HEOR • Real-world • Real-world evidence • CNS Disorders • Insomnia • Sleep Disorder

The Effect of Zolpidem on CPAP Acclimatization in Patients with OSA: A Crossover, Randomized, Double-blinded, Placebo-controlled Trial. (WSS 2025) - "Hypnotic medications, particularly eszopiclone, were shown to be beneficial in CPAP adaptation... This article highlights the value of employing various CPAP acclimatization approaches during the CPAP introduction period instead of focusing on the regular use of zolpidem. Further studies with larger sample sizes and long-term follow-up are recommended."

Clinical • Obstructive Sleep Apnea

Study on the Anesthetic Effect of Local Nerve Block Combined with General Anesthesia in Patients Undergoing Laparoscopic Surgery (ChiCTR) - P=N/A | N=200 | Not yet recruiting | Sponsor: Sir Run Run Hospital Affiliated to Nanjing Medical University; Sir Run Run Hospital Affiliated to Nanjing Medical University

New trial • Anesthesia

Research on the application of network cognitive behavioral therapy in sleep disorders in patients transferred out of ICU (ChiCTR) - P=N/A | N=56 | Not yet recruiting | Sponsor: The Affiliated Hospital of North Sichuan Medical College; The Affiliated Hospital of North Sichuan Medical College

New trial • CNS Disorders • Sleep Disorder

Synergistic effects of combined hypnotic drugs on sleep in mice. (PubMed, Front Pharmacol) - "To investigate the interaction and potential mechanisms of the combined administration of dexmedetomidine (DMED) and eszopiclone (ESZ) on sleep in mice. This study reveals that the combination of DMED and ESZ exerts a synergistic effect on sleep in mice. The underlying mechanism may involve the prolongation of NREM sleep, modulation of neuronal activity in the brain regions of VLPO and TMN, as well as alteration in the levels of brain neurotransmitters."

Journal • Preclinical • CNS Disorders • FOS

Adverse events of pharmacological interventions for insomnia disorder in adults: a systematic review and network meta-analysis. (PubMed, Front Psychiatry) - "Compared with placebo, zolpidem (somnolence: relative risk [RR] 1.85; dizziness: RR 2.33; headache: RR 1.26), zopiclone (somnolence: RR 2.02; dizziness: RR 2.33; dysgeusia: RR 7.84), indiplon (somnolence: RR 3.46; dizziness: RR 2.30; headache: RR 1.63), gaboxadol (dizziness: RR 3.44), eszopiclone (somnolence: RR 2.00; dizziness: RR 3.18; dysgeusia: RR 10.54), estazolam (somnolence: RR 2.08), flunitrazepam (somnolence: RR 3.04), flurazepam (somnolence: RR 2.52), lemborexant (somnolence: RR 6.57), nitrazepam (somnolence: RR 3.80), Ramelteon (somnolence: RR 2.19), suvorexant (somnolence: RR 3.32), Temazepam (somnolence: RR 3.77), trazodone (somnolence: RR 2.86), triazolam (somnolence: RR 2.35), and esmirtazapine (somnolence: RR 4.63; dizziness: RR 2.87) had the most harmful profile in nervous system disorders...Data on some drugs like flurazepam, nitrazepam, triazolam, and zaleplon in some outcomes were mainly based on limited study with rare event and thus was highly..."

Adverse events • Journal • Retrospective data • Review • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Insomnia • Otorhinolaryngology • Pain • Psychiatry • Respiratory Diseases • Sinusitis • Sleep Disorder • Xerostomia

Impact of Promotional Activities on Orexin Receptor Antagonists Prescription Rates and Usage of Sleep and Antipsychotic Medications: An Interrupted Time-series Analysis Study (PubMed, Yakugaku Zasshi) - "The drugs analyzed included lemborexant, zolpidem and eszopiclone (NBDs), and risperidone and quetiapine (DTAs). Promoting ORAs increased its use, and led to a reduction in the prescriptions of NBDs and DTAs with abnormal indications. Although there was no change in patient conditions, given the adverse effects associated with NBDs and DTAs these changes suggest a shift toward safer drug treatment practices."

Journal • CNS Disorders

Endotypic Traits and Obstructive Sleep Apnea Surgery (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: University of California, Los Angeles | Trial completion date: Aug 2027 ➔ Aug 2028 | Trial primary completion date: Aug 2027 ➔ Aug 2028

Trial completion date • Trial primary completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Dementia and Sleep Disorders: The Effects of Drug Therapy in a Systematic Review. (PubMed, Int J Mol Sci) - "Zopiclone increased the main duration of nighttime sleep by 81 min, Zolpidem reduced nighttime awakenings by 21 min, and Eszopiclone improved sleep quality, benefited the progression of sleep architecture, and reduced mental symptoms such as fear and anxiety. Z-drugs show superior efficacy and safety over benzodiazepines, improving sleep and cognitive symptoms in dementia. Personalized treatment and further research across dementia subtypes are needed to optimize long-term outcomes."

Clinical • Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia • Mood Disorders • Psychiatry • Sleep Disorder

Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN) (clinicaltrials.gov) - P4 | N=150 | Recruiting | Sponsor: University of Sao Paulo

New P4 trial • Cardiovascular • CNS Disorders • Hypertension • Insomnia • Sleep Disorder