NIPH Clinical Trials Search

UMIN ID: UMIN000024462

Registered date:18/10/2016

Evaluation of withdrawal symptoms and prognosis of eszopiclone - treated chronic insomnia patients

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedchronic insomnia
Date of first enrollment2016/10/20
Target sample size180
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)I give 2 mg of Eszopiclone once orally before going to bed.


Primary OutcomeMean/median of sleep withdrawal symptoms questionnaire
Secondary Outcome(1) sleeping drug withdrawal syndrome incidence (2) Means/medians of ISI, SF-8 and Bendep-SRQ SV (3) Factors which correlate with sleep withdrawal symptoms questionnaire (e.g. ISI, SF-8, Bendep-SRQ SV, Population dynamics, etc.) (4) Factors which correlate with ISI, SF-8 in the 24th week (e.g. ISI,SF-8 in the 4th week, Population dynamics, etc.) (5) Remission rate end of 2 weeks administration <Safety> Number and incidence of adverse events and the expression number of side effects, incidence

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum65years-old
GenderMale and Female
Include criteria
Exclude criteria(1)Patients taking hypnotics within two weeks before registration (2)Patient having or having anamnestic history of following diseases, risk of suicide, (mild)manic episode, post-traumatic stress disorder, alcohol dependency and abuse, drug(non-alcoholic) dependency and abuse, anorexia nervosa, bulimia nervosa, antisocial personality disorder (3)Patients with drug-induced insomnia (4)Patients with other sleep disorders (circadian rhythm disorder, restless legs syndrome, periodic limb movement disability, sleep apnea syndrome, etc.) (5)Patients with symptoms such as pain, fever, diarrhea, frequent urination, and coughs that remarkably disturbs sleep (6)Patients under unstable condition of underlying disease that causes insomnia for 4 weeks before obtaining informed consent (7)Patients with possibility of organic mental disorder (8)Patients who are engaged in driving a car or operating a risky machine (9)Patients of shift work workers and patients with jet lag (10)Patients with anamnestic history of hypersensitivity for eszopiclone or zopiclone (11)Patient with myasthenica gravis (12)Patients with acute narrow-angle glaucoma (13)Patients with highly impaired respiratory function by pulmonary heart, emphysema, bronchial asthma or acute phase of cerebrovascular disorders (14)Patients who are determined unsuitable by principal investigators

Related Information


public contact
Name Kiyomi Ishii
Address 2-14-1,Nihonbashi,Chuo-ku,Tokyo 103-0027 Japan Japan
Telephone 03-6386-8800
Affiliation APO PLUS STATION Co.,LTD Clinical Study Dept.CRO Business Div
scientific contact
Name Yuichi Inoue
Address 1-24-10,Yoyogi,shibuya-ku,Tokyo151-0053, Japan
Telephone 03-3374-9112
Affiliation Yoyogi Sleep Disorder Center NA