AccScience Publishing / JCBP / Online First / DOI: 10.36922/JCBP025010103
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ORIGINAL RESEARCH ARTICLE

Effect of zaleplon capsules on subjective sleep quality and daytime function in patients with insomnia: A multicenter, single-arm, prospective clinical trial

Suzhen Chen1,2 ,  Shuai Wang3 ,  Zongling He4 ,  Yuhan Bao5 ,  Xiaojuan Ma6 ,  Shaohong Zou7 ,  Hao Huang8 ,  Minghu Cui9 ,  Man Wang10 ,  Yonggui Yuan1,2*
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1 Department of Psychosomatics and Psychiatry, Zhongda Hospital, School of Medicine, Jiangsu Provincial Key Laboratory of Brain Science and Medicine, Southeast University, Nanjing, Jiangsu, China
2 Institute of Psychosomatics, School of Medicine, Southeast University, Nanjing, Jiangsu, China
3 Department of Sleep, Weihai Municipal Third Hospital, Weihai, Shandong, China
4 Department of Sleep Medicine, The Fourth People’s Hospital of Chengdu, Chengdu, Sichuan, China
5 Department of Radiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
6 Department of Psychology, The Ninth People’s Hospital of Zhengzhou, Zhengzhou, Henan, China
7 Department of Clinical Psychology, People’s Hospital of Xinjiang Uygur Autonomous Region, Wulumuqi, Xinjiang Uygur Autonomous Region, China
8 Department of Neurology, The Affiliated Hospital of Zunyi Medical University, Key Laboratory of Brain Function and Brain Disease Prevention and Treatment of Guizhou Province, Zunyi, Guizhou, China
9 Department of Psychology, Binzhou Medical University Hospital, Binzhou, Shandong, China
10 Department of Psychosomatics and Psychiatry, Shenzhen People’s Hospital, Shenzhen, Guangdong, China
JCBP, 025010103 https://doi.org/10.36922/JCBP025010103
Received: 30 December 2025 | Revised: 4 February 2026 | Accepted: 26 February 2026 | Published online: 1 April 2026
© 2026 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
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Abstract

Insomnia is characterized by difficulties in sleep initiation, maintenance, or early morning awakenings, accompanied by impaired daytime functioning and potential progression to depression or anxiety. Zaleplon, a non-benzodiazepine hypnotic selectively targeting the benzodiazepine-1 receptor within the gamma-aminobutyric acid receptor complex, has shown efficacy without rebound insomnia or dependence. This multicenter, single-arm, prospective trial enrolled 355 Chinese adults (18–65 years) meeting International Classification of Diseases-10 non-organic insomnia criteria with sleep initiation difficulty across nine tertiary hospitals (January 2024–September 2025). Participants received 10 mg zaleplon orally 30 minutes before bedtime for 14 days, alongside standardized sleep hygiene education. Outcomes were assessed via the Insomnia Severity Index (ISI), Fatigue Severity Scale (FSS), Positive and Negative Affect Schedule (PANAS), Generalized Anxiety Disorder-7 (GAD-7), and Patient Health Questionnaire-9 (PHQ-9) at baseline and post-treatment. Of 355 participants, 318 completed the full treatment protocol, with significant improvements (all p < 0.001) in ISI (16.00 ± 4.69 to 7.33 ± 4.05), FSS (34.57 ± 13.07 to 23.14 ± 10.69), PANAS-negative affect (21.58 ± 7.76 to 16.07 ± 5.82), GAD-7 (7.21 4.30 to 3.53 ± 2.84), PHQ-9 (9.15 ± 4.99 to 4.21 ± 3.28), and PANAS-positive affect (22.51 ± 6.99 to 25.95 ± 6.74, p < 0.001). Moderate-to-severe symptom prevalence declined substantially, with a treatment-emergent adverse event incidence of 0.94% (mild, no serious events). Subgroup analyses indicated greater therapeutic response in patients with higher baseline insomnia, anxiety, or depression severity, with significant improvements observed across gender and age subgroups. Collectively, this study demonstrates that zaleplon effectively improves subjective sleep quality, daytime function, and emotional well-being in Chinese patients with insomnia, with favorable safety, supporting its clinical use (Clinical trial registration: ChiCTR2400087469).

Keywords
Insomnia
Zaleplon
Subjective sleep quality
Daytime function
Emotional symptoms
Safety
Funding
This work was supported by the Talent Development in High-Level Hospitals (grant number: CZXM-GSP-RC39).
Conflict of interest
The authors declare that they have no financial or personal relationships related to this work.
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