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Study on effect of zaleplon capsules on subjective sleep quality and daytime function in patients with insomnia

Study on effect of zaleplon capsules on subjective sleep quality and daytime function in patients with insomnia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087469
Enrollment
Unknown
Registered
2024-07-29
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomina

Interventions

insomnia group:Zaleplon Capsules 10mg

Sponsors

ZhongDa Hospital, School of Medicine, Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) aged 18 to 65 years old; (2) insomniacs with difficulty falling asleep (sleep onset latency =30min on at least 3 days per week); (3) non-organic insomnia according to ICD-10 criteria; (4) Informed consent was obtained from patients or their legal guardians.

Exclusion criteria

Exclusion criteria: (1) 3 or more days a week, easy to wake up at night or early awakening; (2) the baseline GAD - 7 or 15 or PHQ - September 20 or more; (3) merging other mental disease or secondary insomnia patients, such as in the use of certain drugs or in organic encephalopathy, serious body disease on the basis of the occurrence of insomnia disorders; (4) there is obstructive sleep apnea, restless leg syndrome or rem sleep behavior disorder, excessive sleepiness barriers and any may affect the results of the study of disease states; (5) history of alcohol and drug dependence and serious diseases such as malignant tumors; (6) patients with the experience of using sedatives and hypnotics to treat insomnia in the past two weeks; (7) pregnant and lactating women; (8) Allergy to any component of Zaleplon capsule or contraindication to its use according to the instructions.

Design outcomes

Primary

MeasureTime frame
Subjective degree of sleep disorders;Daytime emotions;Subjective fatigue level;

Secondary

MeasureTime frame
Anxiety symptoms;Depressive symptoms;

Countries

China

Contacts

Public ContactYuan Yonggui

ZhongDa Hospital, School of Medicine, Southeast University

yygylh2000@sina.com+86 25 8328 5125

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026