The Comparative Effectiveness and Safety of Insomnia Drugs: A Systematic Review and Network Meta-Analysis of 153 Randomized Trials

Pan, Bei; Ge, Long; Lai, Honghao; Hou, Liangying; Tian, Chen; Wang, Qi; Yang, Kelu; Lü, Yao; Zhu, Hongfei; Li, Mengting; Wang, Deren; Li, Xiuxia; Zhang, Yuqing; Gao, Ya; Liu, Ming; Ding, Guowu; Tian, Jinhui; Yang, Kun

doi:10.1007/s40265-023-01859-8

Cited by 16 publications

(3 citation statements)

References 157 publications

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“…We selected 1 meta-analysis published in 2021, 20 2 published in 2023, 21 , 22 and 1 systematic review. 23 The analyses focused on the associations between red meat intake and cardiometabolic and cancer outcomes, the efficacy and safety of type 2 diabetes treatments, and drug therapies for primary insomnia, respectively.…”

Section: Resultsmentioning

confidence: 99%

Assessing the Risk of Bias in Randomized Clinical Trials With Large Language Models

Lai,

Ge,

Sun

et al. 2024

JAMA Netw Open

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ImportanceLarge language models (LLMs) may facilitate the labor-intensive process of systematic reviews. However, the exact methods and reliability remain uncertain.ObjectiveTo explore the feasibility and reliability of using LLMs to assess risk of bias (ROB) in randomized clinical trials (RCTs).Design, Setting, and ParticipantsA survey study was conducted between August 10, 2023, and October 30, 2023. Thirty RCTs were selected from published systematic reviews.Main Outcomes and MeasuresA structured prompt was developed to guide ChatGPT (LLM 1) and Claude (LLM 2) in assessing the ROB in these RCTs using a modified version of the Cochrane ROB tool developed by the CLARITY group at McMaster University. Each RCT was assessed twice by both models, and the results were documented. The results were compared with an assessment by 3 experts, which was considered a criterion standard. Correct assessment rates, sensitivity, specificity, and F1 scores were calculated to reflect accuracy, both overall and for each domain of the Cochrane ROB tool; consistent assessment rates and Cohen κ were calculated to gauge consistency; and assessment time was calculated to measure efficiency. Performance between the 2 models was compared using risk differences.ResultsBoth models demonstrated high correct assessment rates. LLM 1 reached a mean correct assessment rate of 84.5% (95% CI, 81.5%-87.3%), and LLM 2 reached a significantly higher rate of 89.5% (95% CI, 87.0%-91.8%). The risk difference between the 2 models was 0.05 (95% CI, 0.01-0.09). In most domains, domain-specific correct rates were around 80% to 90%; however, sensitivity below 0.80 was observed in domains 1 (random sequence generation), 2 (allocation concealment), and 6 (other concerns). Domains 4 (missing outcome data), 5 (selective outcome reporting), and 6 had F1 scores below 0.50. The consistent rates between the 2 assessments were 84.0% for LLM 1 and 87.3% for LLM 2. LLM 1’s κ exceeded 0.80 in 7 and LLM 2’s in 8 domains. The mean (SD) time needed for assessment was 77 (16) seconds for LLM 1 and 53 (12) seconds for LLM 2.ConclusionsIn this survey study of applying LLMs for ROB assessment, LLM 1 and LLM 2 demonstrated substantial accuracy and consistency in evaluating RCTs, suggesting their potential as supportive tools in systematic review processes.

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Section: Resultsmentioning

confidence: 99%

Assessing the Risk of Bias in Randomized Clinical Trials With Large Language Models

Lai,

Ge,

Sun

et al. 2024

JAMA Netw Open

Self Cite

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“…Dual orexin receptor antagonists (DORAs) are novel treatments for insomnia. Several clinical trials and meta-analyses [16][17][18][19][20] showed for all DORAs an improvement in total sleep time in a dose-dependent manner and an improvement in sleep maintenance (suvorexant, [17,[19][20][21], and for daridorexant, [18][19][20]). In a phase II trial, using a randomized, double-blind, placebo-controlled, active-reference (here: zolpidem) study design, only daridorexant reduced the number and duration of longer wake bouts throughout the night compared with placebo [22].…”

Section: Insomniamentioning

confidence: 99%

“…In a phase II trial, using a randomized, double-blind, placebo-controlled, active-reference (here: zolpidem) study design, only daridorexant reduced the number and duration of longer wake bouts throughout the night compared with placebo [22]. Two meta-analyses on daridorexant, however, found no beneficial effect on insomnia [16,17]. In a recent study on the comparison of the treatment effectiveness between lemborexant and zolpidem, both drugs, but lemborexant more consistently, showed subjective and objective (polysomnographic findings) benefits compared with placebo [23].…”

Section: Insomniamentioning

confidence: 99%

Pharmacological Treatments of Sleep–Wake Disorders: Update 2023

Kallweit,

Kallweit

2023

CTN

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Biological, environmental, behavioral, and social factors can influence sleep and lead to sleep disorders or diseases. Sleep disorders are common, numerous, and heterogeneous in terms of their etiology, pathogenesis, and symptomatology. The management of sleep–wake circadian disorders (SWCDs) includes education on sleep hygiene, behavioral strategies, psychotherapy (cognitive behavioral therapy (CBT), particularly), instrument-based treatments (i.e., positive airway pressure therapy, hypoglossal nerve stimulation), and pharmacotherapy. Depending on the disease, therapy varies and is executed sequentially or can be a combination of several forms of therapy. Drugs used for SWCDs include traditional sleep- or wake-promoting agents and chronotherapeutic agents. Recently, novel medications, which more precisely act on specific neurochemical systems (i.e., the orexin system) important for sleep and waking, are also increasingly being used. In this review, the pharmacotherapy of common sleep disorders (insomnia, sleep-related breathing disorder, central disorders of hypersomnolence, circadian rhythm sleep–wake disorders, parasomnias, and sleep-related movement disorders) embedded in the overall therapeutic concept of each disorder is presented. There is also an outlook on possible future pharmacotherapies.

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Triphala ameliorates cognitive deficits and anxiety via activation of the Nrf2/HO-1 axis in chronic sleep-deprived mice

Wang,

He,

Rangji

et al. 2024

International Immunopharmacology

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The Comparative Effectiveness and Safety of Insomnia Drugs: A Systematic Review and Network Meta-Analysis of 153 Randomized Trials

Cited by 16 publications

References 157 publications

Assessing the Risk of Bias in Randomized Clinical Trials With Large Language Models

Assessing the Risk of Bias in Randomized Clinical Trials With Large Language Models

Pharmacological Treatments of Sleep–Wake Disorders: Update 2023

Triphala ameliorates cognitive deficits and anxiety via activation of the Nrf2/HO-1 axis in chronic sleep-deprived mice

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