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Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder
Led by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. · Updated on 2025-07-15
60
Participants Needed
16
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to assess efficacy of YZJ-1139 for 28 days in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
CONDITIONS
Official Title
Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to under 65 years.
- Meet clinical diagnostic criteria for insomnia disorder (ICSD-3).
- Sleep onset latency of 30 minutes or more for at least 3 nights per week and/or wake after sleep onset of 60 minutes or more for at least 3 nights per week within 4 weeks before screening.
- Able to recognize 26 English letters and have no cognitive impairment based on MMSE score.
- During run-in and Day 1 of treatment, sleep onset latency of 30 minutes or more for at least 3 nights in 7 days and/or wake after sleep onset of 60 minutes or more for at least 3 nights confirmed by sleep diary.
- Polysomnography during run-in shows mean latency to persistent sleep of at least 30 minutes for 2 nights and/or mean wake after sleep onset of at least 60 minutes for 2 nights; sleep efficiency 85% or less for 2 nights.
- Insomnia Severity Index (ISI) score of 15 or higher at screening and Day 1.
- Bedtime between 9 p.m. and 1 a.m., wake time between 5 a.m. and 10 a.m., and in-bed time of 6.5 to 9 hours for at least 5 nights in last 7 days.
- Agreement to use effective contraception from screening through 30 days after last dose, if of reproductive age.
- Understand study procedures, voluntarily consent, and agree to attend study visits with good compliance.
You will not qualify if you...
- Allergy or hypersensitivity to YZJ-1139, zolpidem, or their ingredients.
- Serious medical conditions affecting safety or study assessments, including endocrine, blood, heart, brain, gastrointestinal, liver, kidney, autoimmune, or respiratory diseases.
- Insomnia caused by other physical conditions like chronic pain, eczema, or allergies.
- History of psychiatric or neurological diseases such as epilepsy, schizophrenia, bipolar disorder, cognitive disorders, or other mental illnesses affecting safety or assessments.
- Past or current sleep-related respiratory or movement disorders including sleep apnea, restless legs syndrome, narcolepsy, or periodic limb movement disorder.
- History of complex sleep behaviors like sleep driving or sleep eating.
- Nocturia caused by urinary or prostate issues.
- Hyperthyroidism.
- Recent history of alcohol abuse or excessive caffeine intake.
- Smoking more than 10 cigarettes per day recently or inability to refrain from smoking.
- Lifestyle factors interfering with study, such as travel across multiple time zones or shift work.
- History of drug abuse or positive drug screening.
- Use of certain medications affecting sleep within 1 week before run-in.
- Planned surgery during study.
- Depression or anxiety above defined severity thresholds.
- Suicidal ideation or behavior within recent years.
- Abnormal ECG or liver/kidney function tests.
- HIV positive status.
- Sleep study abnormalities above defined limits.
- Recent vaccination.
- Participation in other clinical trials recently.
- Prior participation in YZJ-1139 trials or treatment with similar drugs with treatment failure.
- Pregnant or breastfeeding women.
- Any other conditions judged unsuitable by investigator.
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Peking University People's Hospital
Beijing, China
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2
ChengDu Second People's Hospital
Chengdu, China
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3
ChongQing Traditional Chinese Medicine Hospital
Chongqing, China
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4
Deyang People's Hospital
Deyang, China
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5
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Guangzhou, China
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6
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Jinan, China
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7
The Second Affiliated Hospital Of NanChang University
Nanchang, China
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8
The First Affiliated Hospital of Ningbo University
Ningbo, China
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9
ShengJing Hospital Of China Medical University
Shenyang, China
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10
The Third Hospital of Hebei Medical University
Shijiazhuang, China
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11
SuZhou GuangJi Hospital
Suzhou, China
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12
The Second Affiliated Hospital of Soochow University
Suzhou, China
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13
Tianjin Anding Hospital
Tianjin, China
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14
Wuhan No.1 Hospital
Wuhan, China
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15
Yan'an University Xianyang Hospital
Yan’an, China
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16
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, China
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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