Open Access Research article

Ramelteon combined with an α1-blocker decreases nocturia in men with benign prostatic hyperplasia

Takashi Kawahara125*, Satoshi Morita3, Hiroki Ito12, Hideyuki Terao1, Ryoko Sakata2, Hitoshi Ishiguro5, Katsuyuki Tanaka4, Hiroshi Miyamoto5, Junichi Matsuzaki1, Yoshinobu Kubota2 and Hiroji Uemura2*

Author Affiliations

1 Department of Urology, Ohguchi Higashi General Hospital, Yokohama, Kanagawa, Japan

2 Department of Urology, Yokohama City University Graduate School of Medicine, 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan

3 Department of Biostatistics and Epidemiology, Yokohama City University Graduate School of Medicine, Yokohama, Japan

4 Department of Urology, Kanagawa Rehabilitation Hospital, Atsugi, Kanagawa, Japan

5 Department of Pathology and Laboratory Medicine, University of Rochester Medical Center, Rochester, NY, USA

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BMC Urology 2013, 13:30  doi:10.1186/1471-2490-13-30

Published: 12 June 2013



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.


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.


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.


Ramelteon in combination with an α1-blocker could be a treatment option for reducing nocturia in men with BPH.

Ramelteon; Melatonin; Nocturia; Benign prostate hyperplasia; α1-blocker