title: Ramelteon combined with an α1-blocker decreases nocturia in men with benign prostatic hyperplasia.
abstract: BACKGROUND
  Nocturia is defined as waking one or more times during the night due to the urge to void. Recently, the effectiveness of several sedatives and analgesics for nocturia has been reported. We herein investigated the effects of ramelteon, an antioxidant and sleep inducer, on nocturia unresponsive to α1-blocker monotherapy in males with lower urinary tract symptoms (LUTS) as a pilot study.
  
  
  METHODS
  Subjects were 19 patients who had LUTS suggestive of benign prostate hyperplasia, received α1-blockers (tamsulosin, silodosin, or naftopidil), and continued to have two or more episodes of nocturia per night before starting ramelteon. Ramelteon at 8 mg once daily for one month was added to the α1-blocker. A self-administered questionnaire including the International Prostate Symptom Score (IPSS), quality of life (QoL) index, Overactive Bladder Symptom Score (OABSS), and Nocturia Quality-of-Life Questionnaire (N-QOL) were assessed before and one month after starting ramelteon.
  
  
  RESULTS
  The mean score on IPSS question 7 (nocturia) decreased significantly from 2.88 before starting ramelteon to 2.41 one month after starting the medication (P = 0.03). The mean total OABSS decreased significantly from 6.31 to 5.38 (P = 0.03), and the mean for OABSS question 2 (nighttime frequency of nocturia) also significantly decreased from 2.63 to 2.13 (P = 0.01). The mean total N-QOL score did not change significantly. Two patients had dizziness; the remaining patients had no adverse drug-related events.
  
  
  CONCLUSIONS
  Ramelteon in combination with an α1-blocker could be a treatment option for reducing nocturia in men with BPH.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kawahara
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Hiroki
authors.initials: H
authors.lastname: Ito
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Terao
authors.forename: Ryoko
authors.initials: R
authors.lastname: Sakata
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Ishiguro
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Tanaka
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Miyamoto
authors.forename: Junichi
authors.initials: J
authors.lastname: Matsuzaki
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Kubota
authors.forename: Hiroji
authors.initials: H
authors.lastname: Uemura
mesh_terms: D058668:Adrenergic alpha-1 Receptor Antagonists / Q000008:administration & dosage*; D000368:Aged; D000975:Antioxidants / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D006801:Humans; D007192:Indenes / Q000008:administration & dosage*; D008297:Male; D053158:Nocturia / Q000175:diagnosis / Q000209:etiology* / Q000517:prevention & control*; D010865:Pilot Projects; D011470:Prostatic Hyperplasia / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D000975:Antioxidants; D007192:Indenes; C495910:ramelteon