Efficacy of Ramelteon in Patients with Insomnia and Nocturia

Shimizu, Nobuyoshi; Sugimoto, Koichi; Nozawa, Masahiro; Kobayashi, Yasuyuki; Yamamoto, Yutaka; Minami, Takafumi; Hayashi, Taiji; Yoshimura, Kazuhiro; Ishii, Tokumi; Uemura, Hirotsugu; Nose, Kazuhiro; Nishioka, Tsukasa

doi:10.1111/j.1757-5672.2012.00166.x

Cited by 11 publications

(31 citation statements)

References 13 publications

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“…Ramelteon is a melatonin MT1 and MT2 receptor agonist that is recently reported to be effective for nocturia [16]. In the present study, both ramelteon and zolpidem proved nocturia in patients who had shown a poor response to alpha-1 antagonists, anticholinergic agents, and/or herbal medicines.…”

Section: Resultsmentioning

confidence: 55%

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

Mukouyama¹,

Sugaya²,

Nishijima³

et al. 2013

OJU

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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 (2 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.

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Section: Resultsmentioning

confidence: 55%

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

Mukouyama¹,

Sugaya²,

Nishijima³

et al. 2013

OJU

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“…Kaye et al reported that oxazepam and naproxem, among five different sedatives and analgesics, significantly decreased nocturia [17]. Shimizu et al reported that ramelteon decreased nocturia in a cohort of 49 patients, including patients with insomnia with prostate cancer and BPH, and those who had undergone radical prostatectomy [10]. The number of nocturia episodes was decreased from 3.1 to 2.2 per night in that study (P < 0.001).…”

Section: Discussionmentioning

confidence: 85%

“…Drake et al reported the effectiveness of melatonin for nocturia in a randomized, double-blind, placebo-controlled crossover study in 20 men [9] Shimizu et al reported that ramelteon significantly decreased the nocturia for patients who had both LUTS and insomnia [10]. Ramelteon, the first melatonin receptor agonist approved by the United States and Japan, is a selective MT1 and MT2 agonist, [11] and its efficacy and safety for chronic insomnia has been reported [12,13].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2013

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BackgroundNocturia 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.MethodsSubjects 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.ResultsThe 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.ConclusionsRamelteon in combination with an α1-blocker could be a treatment option for reducing nocturia in men with BPH.

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“…For example, in preliminary studies in anxiety disorder patients, ramelteon (n = 27, 8 mg, 12-week open-label) showed a significant improvement of sleep parameters (shorter latency, increased TST and reduction of daytime sleepiness), as well as a reduction in anxiety symptoms [83]. There is also evidence that ramelteon (8 mg/day, 4 weeks, n = 49) can alleviate nocturia and disturbed sleep in patients with insomnia and nocturia [84], and is effective for the treatment of insomnia in menopausal women [52]. Current clinical studies are evaluating the applicability of ramelteon in other disorders including CRSDs, delirium, euthymic bipolar disorders, visual hallucinations in dementia, neuropathic pain, migraine and so on.…”

Section: Expert Opinionmentioning

confidence: 98%

Pharmacokinetic and pharmacodynamic evaluation of ramelteon: an insomnia therapy

Spadoni

Bedini

Lucarini

et al. 2015

Expert Opinion on Drug Metabolism & Toxicology

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Despite its high prevalence and economic burden, insomnia disorder remains mostly untreated. Ramelteon has demonstrated sleep-promoting effects in clinical trials and clinical practice, and it is not associated with the adverse effects typical of other class of hypnotics. Its efficacy appears to be relatively modest compared to current insomnia therapeutics, and its use seems restricted to patients with sleep onset difficulties. Assessment of ramelteon effects on sleep quality and maintenance, daytime function and of improvements in comorbid insomnia conditions deserves further studies. The potential application of ramelteon in other pathological conditions could open the way to novel therapeutic approaches as well as to new market opportunities.

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Efficacy of Ramelteon in Patients with Insomnia and Nocturia

Cited by 11 publications

References 13 publications

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

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

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

Pharmacokinetic and pharmacodynamic evaluation of ramelteon: an insomnia therapy

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