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

UMIN ID: UMIN000024462

Registered date:18/10/2016

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: chronic insomnia
• Date of first enrollment: 2016/10/20
• Target sample size: 180
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): I give 2 mg of Eszopiclone once orally before going to bed.

Outcome(s)

• Primary Outcome: Mean/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 minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• 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

• Primary Sponsor: Yoyogi Sleep Disorder Center
• Source(s) of Monetary Support: Eisai Co.,Ltd