Double-blind randomized controlled study of the efficacy, safety and tolerability of eszopiclone vs placebo for the treatment of patients with post-traumatic stress disorder and insomnia

作     者：Sheila M Dowd Alyson K Zalta Helen J Burgess Elizabeth C Adkins Zerbrina Valdespino-Hayden Mark H Pollack 

作者机构：Department of Psychiatry and Behavioral SciencesRush University Medical CenterChicagoIL 60601United States Department of Psychological ScienceUniversity of California IrvineIrvineCA 92697United States Sleep and Circadian Research LaboratoryDepartment of PsychiatryUniversity of MichiganAnn ArborMI 48109United States Center for Behavioral Intervention Technologies|Department of Preventive MedicineNorthwestern University Feinberg School of MedicineChicagoIL 60611United States Department of PsychologyMontclair State UniversityMontclairNJ 07043United States 

出 版 物：《World Journal of Psychiatry》 (世界精神病学杂志)

年 卷 期：2020年第10卷第3期

页      面：21-28页

核心收录：

学科分类：1002[医学-临床医学] 100205[医学-精神病与精神卫生学] 10[医学] 

基　　金：Supported by National Institute of Mental Health No.5R34MH91338-03 and No.K23 MH103394(to Zalta AK) 

主　　题：Trauma Sleep disturbance Hypnotic Post-traumatic stress disorder 

摘      要：BACKGROUND Sleep disturbance is a core feature of post-traumatic stress disorder(PTSD).Given the relationship between sleep disturbance and PTSD,there has been a relative paucity of studies examining the potential therapeutic impact of using pharmacotherapy to target sleep disturbance in patients with PTSD.Eszopiclone(ESZ)is a non-benzodiazepine y-aminobutyric acid-A receptor agonist indicated for the treatment of sleep and may affect sleep in patients with PTSD.AIM To evaluate the efficacy of ESZ vs placebo(PBO)for patients with PTSD and insomnia.METHODS The study was a 12-wk,double blind,randomized controlled trial with 3 mg of ESZ(n=13)or PBO(n=12).RESULTS Patients in both arms experienced significant improvement in PTSD symptoms as assessed by the Clinician-Administered PTSD Scale for DSM-IV(CAPS):ESZ(t11=-3.12,P=0.005)and PBO(t11=-3.5,P=0.002)and by self-report with the Short PTSD Rating Interview(ESZ t11=-3.38,P=0.003 and PBO t11=-4.48,P=0.0005).There were no significant differences between treatments on the CAPS(t22=-0.13,P=0.70)or the Short PTSD Rating Interview(t22=-0.58,P=0.56).Similarly,both treated groups improved on sleep measures as assessed by the Pittsburgh Sleep Quality Index with PTSD Addendum(PSQI)and on total sleep time(TST)and sleep latency assessed by actigraphy with no significant differences between groups(PSQI t22=-0.24,P=0.81;total sleep time t10=0.13,P=0.90 and sleep latency t10=0.68,P=0.50).There was a significant correlation between improvement in sleep and overall improvement in PTSD as measured by change scores on the PSQI and CAPS,r(8)=0.79,P=0.01 for ESZ treated subjects,but not for those treated with PBO r(9)=0.16,P=0.69.Adverse events of ESZ were consistent with the known profile of the medication including dysgeusia(30%,mild),sedation(20%,mild)and headache(20%,moderate to severe).CONCLUSION Results do not support the hypothesis of a specific positive effect of ESZ compared to PBO for measures of PTSD and associated sleep disturbance.