title: Therapeutic efficacy and anti-inflammatory effect of ramelteon in patients with insomnia associated with lower urinary tract symptoms.
abstract: OBJECTIVE
  This study was conducted to examine the therapeutic efficacy and anti-inflammatory effect of ramelteon in elderly patients with insomnia associated with lower urinary tract symptoms (LUTS), who visited our urology department.
  
  
  METHODS
  The study included 115 patients (102 men, 13 women) who scored ≥4 on the Athens Insomnia Scale and who wished to receive treatment. The assessment scales for therapeutic efficacy included the International Prostate Symptom Score (IPSS) for LUTS and the Insomnia Severity Index (ISI) for sleep disorders. The high-sensitivity C-reactive protein (hs-CRP) test was used to an objective assessment. The patients were treated with ramelteon (8 mg/day) for an average of 10 weeks and were then reexamined using the questionnaires and hs-CRP test to evaluate therapeutic efficacy.
  
  
  RESULTS
  IPSS total scores declined significantly from 11.39 ± 8.78 to 9.4 ± 7.72. ISI total scores improved significantly from 11.6 ± 5.2 to 9.2 ± 5.3 (P < 0.0001). The levels of hs-CRP decreased significantly from 0.082 (standard deviation [SD] upper limit, 0.222; SD lower limit, -0.059) to 0.06 (SD upper limit, 0.152; SD lower limit, -0.032). The ISI scores ≥ 10 (n = 51) showed a weak correlation with the hs-CRP levels.
  
  
  CONCLUSIONS
  Ramelteon had a systemic anti-inflammatory effect and improved sleep disorders and LUTS, suggesting that it may be a useful treatment for patients with LUTS-associated insomnia.
authors.affiliation: Department of Urology, Faculty of Medicine, Kinki University, Osaka, Japan.
authors.forename: Nobutaka
authors.initials: N
authors.lastname: Shimizu
authors.affiliation: Department of Urology, Faculty of Medicine, Kinki University, Osaka, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Nozawa
authors.affiliation: Department of Urology, Sakai Hospital, Faculty of Medicine, Kinki University, Osaka, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Sugimoto
authors.affiliation: Department of Urology, Faculty of Medicine, Kinki University, Osaka, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: Department of Urology, Faculty of Medicine, Kinki University, Osaka, Japan.
authors.forename: Takafumi
authors.initials: T
authors.lastname: Minami
authors.affiliation: Department of Urology, Faculty of Medicine, Kinki University, Osaka, Japan.
authors.forename: Taiji
authors.initials: T
authors.lastname: Hayashi
authors.affiliation: Department of Urology, Faculty of Medicine, Kinki University, Osaka, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yoshimura
authors.affiliation: Department of Urology, Faculty of Medicine, Kinki University, Osaka, Japan.
authors.forename: Tokumi
authors.initials: T
authors.lastname: Ishii
authors.affiliation: Department of Urology, Faculty of Medicine, Kinki University, Osaka, Japan.
authors.forename: Hirotsugu
authors.initials: H
authors.lastname: Uemura
keywords: inflammation; lower urinary tract symptoms; ramelteon; sleep disorders