Comparison of the Melatonin Receptor Agonist Ramelteon and the Non-Benzodiazepine Hypnotic Zolpidem for Nocturia

Hideki Mukouyama,Katsuhiro Ashitomi,Saori Nishijima,Kimio Sugaya,Hidekatsu Naka,Misao Sakumoto,Tomohiro Onaga,Katsumi Kadekawa

doi:10.4236/oju.2013.38055

Abstract

To examine the efficacy of the melatonin receptor agonist ramelteon for nocturia, it was compared with zolpidem, a conventional non-benzodiazepine hypnotic. A total of 50 patients with nocturia (32 urinations/night) were enrolled. Subjects assigned odd numbers or even numbers were respectively prescribed 8 mg of ramelteon (n = 27; mean age: 75 years) or 5 mg of zolpidem (n = 23; mean age: 73 years) once a day before sleeping for 4 weeks. The daytime and nighttime frequencies of urination, as well as the results of global self-assessment by the patients, were compared between the two groups before and after 4 weeks of treatment. Both ramelteon and zolpidem caused a significant decrease of nocturia to about once per night after 4 weeks. The global self-assessment rating at 4 weeks was “good” or “fair” for more patients in the zolpidem group than in the ramelteon group, while the rating was “excellent” or “no change” for more patients in the ramelteon group. There were no serious adverse events in either group. Ramelteon was safe and effective for nocturia, achieving similar results to zolpidem. However, responders and non-responders to ramelteon were more clearly distinguished. Ramelteon might be effective for patients with sleep disturbance and nocturia because of low melatonin levels. Therefore, as diagnostic therapy for identification of nocturia caused by sleep disturbance and melatonin deficiency, ramelteon should be administered to patients who do not respond to alpha-1 antagonists and/or anticholinergic agents.

Highlights

Nocturia is common in the elderly, and is one of the most troublesome urologic symptoms [1,2]
In order to examine the efficacy of ramelteon (Rozerem®) for nocturia, we compared it with zolpidem (Myslee®), a conventional non-benzodiazepine hypnotic (GABAa receptor modulator) [12], in elderly patients with nocturia
There were no significant differences of age, systolic blood pressure, diastolic blood pressure, heart rate, complications, prostate volume, duration of nocturia, daytime and nighttime frequency, Overactive Bladder Symptom Score (OABSS) and International Prostate Symptom Score (IPSS) items, total OABSS, total IPSS, and Quality of Life (QOL) score between the 2 groups (Table 1)

Summary

Introduction

Nocturia is common in the elderly, and is one of the most troublesome urologic symptoms [1,2]. Several prospective studies have shown that nocturia is associated with a higher mortality rate, even after adjustment for confounding factors [3]. Multiple factors may contribute to the occurrence of nocturia, including various pathologi-. Various drugs and other methods have been tried for the treatment of nocturia, including alpha-1 receptor antagonists, anticholinergic agents, nonsteroidal anti-inflammatory drugs, antidepressants (minor tranquilizers), diuretics, desmopressin, hypnotics, and melatonin [8,9]. It is an orally active chrono hypnotic agent that acts selectively on melatonin MT1 and MT2 receptors, which are primarily located in the suprachiasmatic nucleus. In order to examine the efficacy of ramelteon (Rozerem®) for nocturia, we compared it with zolpidem (Myslee®), a conventional non-benzodiazepine hypnotic (GABAa receptor modulator) [12], in elderly patients with nocturia

Materials and Methods

Results

Discussion

Conclusion