Background The primary objective of this study was to evaluate long-term (24-week) safety of eszopiclone in elderly and nonelderly Japanese patients with chronic insomnia. and 87.0% in the 3-mg nonelderly group. Dysgeusia was the most common adverse event and was dose-related. Of 12 serious adverse events, none were considered by the investigator to be related to study medication. No rebound insomnia was observed. Eszopiclone significantly improved SL, TST, WASO, NA, and daytime sleepiness and function from baseline to Week 4, irrespective of age and psychiatric comorbidity. Improvements were also observed in SF-36 Mental Health Component scores in elderly and nonelderly patients with psychiatric comorbidities. Conclusions Irrespective of age, eszopiclone appeared safe as administered in this study for 24?weeks. Eszopiclone improved sleep variables in insomnia patients with and without psychiatric disorders and health-related quality of life in those with psychiatric disorders. Trial registration ClinicalTrials.gov #NCT00770692; http://clinicaltrials.gov/ct2/show/NCT00770692. Fourth Edition, Text Revision (DSM-IV-TR) , or insomnia associated with a physical or psychiatric disorder; (2) presence of reported symptoms with SL 30 minutes on 3 or more nights per week and TST 390 minutes on 3 or more nights per week for 4?weeks or more prior to screening; and (3) presence of symptoms with SL 30 minutes on 3 or more nights (including at least 2 consecutive nights) and TST 390 minutes on 3 or more nights (including at least 2 consecutive nights) as recorded in the patient self-report sleep diary during the screening period. The threshold of TST 390 minutes and the criterion of 2 consecutive nights were used to ensure that the patient population had a level of insomnia severity likely to show a treatment effect. Patients were excluded if they met any of the following criteria: (1) risk of suicide, manic episode, post-traumatic stress disorder (PTSD), history of or current alcohol dependence or abuse, history of or current drug dependence or abuse, anorexia nervosa, bulimia nervosa, or antisocial personality disorder, as diagnosed by the Mini-International Neuropsychiatric Interview (M.I.N.I.) Japanese version 5.0.0; (2) drug-induced insomnia; (3) primary sleep disorders other than primary insomnia (eg, circadian rhythm disorder, restless leg syndrome, periodic limb movement, sleep apnea); (4) severely disturbed sleep by chronic pain, fever, diarrhea, frequent urination, or coughing; (5) organic psychiatric disorder; (6) suicidal ideation or attempt in the past 5?years; (7) clinically severe dysfunction of Rabbit polyclonal to ZNF490. the liver, kidney, cardiovascular system, or hematologic system or presence of a malignant tumor; and (8) pregnancy or breast-feeding. The restricted concomitant medications from 2?weeks before to 4?weeks after starting eszopiclone administration included sedative hypnotics, anxiolytics not indicated for insomnia, Plerixafor 8HCl neurologic disease medications, antiepileptics, Parkinsons disease medications, antihistamines, analgesics, adrenal corticosteroids, bronchovasodilators, melatonin, oriental medicines indicated for insomnia, and herbal preparations or supplements used for insomnia. The prohibited concomitant medications from Day ?10 to the end of study included sedative hypnotics other than eszopiclone, anxiolytics indicated for insomnia, and potent inhibitors and inducers of cytochrome P450 isoenzyme 3A4. Study procedures The study consisted of 10 visits and 4 periods: the screening period (Week ?1; baseline), the first treatment period (Weeks 1 to 4), the second treatment period (Weeks 5 to 24), and the follow-up period (Week 25) (Figure?1). At Day ?7, patients signed written informed consent, had their baseline characteristics (demographics, medications, and sleep, medical, and psychiatric histories) recorded, and completed all other screening procedures, including vital signs, ECG, and clinical laboratory tests. Figure 1 Summary of study schematic from screening through study completion. Visits 6, 7, and 8 were conducted at 4-week intervals. Adverse events were collected from Weeks 1 to 25. Sleep Plerixafor 8HCl variables were obtained at Week ?1 (baseline) and Weeks 1 to 4. … Patients who met Plerixafor 8HCl inclusion criteria to enter into the screening period were instructed to complete a self-report sleep diary for 1?week. Patients used the diary to record various sleep parameters, such as SL, TST, and WASO. At Day 0, SL and TST for the previous 7?days were assessed to judge the eligibility for study treatment. The principal investigators and sub-investigators were able to make a clinical diagnosis of primary insomnia, insomnia associated with a physical disorder, or insomnia associated with a psychiatric disorder by taking underlying physical conditions Plerixafor 8HCl and psychiatric conditions into consideration. Drug allocation was performed by stratified block randomization.