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Researchers cancel registration!! Efficacy and safety assessment of conversion to didarcinide in insomnia patients dissatisfied with conventional benzodiazepine-based sedative hypnotics: a single-center, prospective, observational study

Efficacy and safety assessment of conversion to didarcinide in insomnia patients dissatisfied with conventional benzodiazepine-based sedative hypnotics: a prospective, observational study

Status
Unknown
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102474
Enrollment
Unknown
Registered
2025-05-15
Start date
2025-06-01
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Insomnia

Interventions

Didacini Formation Group:Insomniacs who are dissatisfied with traditional benzodiazepines (BZDs) are switched to didarzenil.

Sponsors

Anqing City Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-65 years old, gender is not limited; 2.Insomnia patients who have been taking estazolam, alprazolam, clonazepam, or lorazepam (only one of them) at least 3 nights a week within 2 weeks before the start of conversion treatment, and are not satisfied with the treatment effect or safety (overall satisfaction at baseline <4) and wish to switch to other drugs; 3.Intended to be treated with Ditarcini; 4.Ensure at least 7 hours of sleep; 5.Voluntary written informed consent.

Exclusion criteria

Exclusion criteria: 1.Presence of contraindications to didarzenil: including allergy to any vehicle of didarzenil, severe obstructive sleep apnea (OSA), respiratory insufficiency, or myasthenia gravis; 2.Treatment with two or more benzodiazepine receptor agonists; 3.Use of two or more drugs or health care products that regulate sleep function or affect sleep other than benzodiazepines within 7 days or less than 5 drug half-lives prior to enrollment; 4.Newly initiated non-pharmacological treatments for insomnia (e.g. cognitive behavioral therapy, physical therapy, etc.) within 1 week prior to the start of conversion therapy; 5.Women during pregnancy and lactation; 6.Other circumstances considered inappropriate by the investigator for participation in this clinical study.

Design outcomes

Primary

MeasureTime frame
Likert-7 points Overall Satisfaction Rating;

Countries

China

Contacts

Public ContactHuang Dawei

Anqing City Sixth People's Hospital

624062949@qq.com+86 181 0966 8171

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026