Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0917801 (insomnia)
 10,606 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The aim of this study was to evaluate the efficacy and safety of ramelteon 4, 8, 16 or 32 mg and placebo in Japanese patients with chronic insomnia using a randomized, double-blind, five-period crossover design. A total of 65 Japanese patients with chronic primary insomnia received ramelteon or placebo for two nights each in sleep laboratories. Changes in sleep parameters were assessed objectively by polysomnography and subjectively by postsleep questionnaires. Safety and tolerability was evaluated by assessment of the occurrence of adverse events, next-day residual effects and laboratory and ECG investigations. Ramelteon 8 and 32 mg significantly shortened the mean latency to persistent sleep in comparison with placebo, and there was a statistically significant trend for linear dose-response for this sleep parameter. Overall changes in sleep architecture were modest (<3% changes vs placebo), with increases in stage 1 and decreases in stage 3/4. Ramelteon was well tolerated, the most common adverse effect being somnolence, which was similar to placebo at doses up to 8 mg, but increased with higher doses. Next-day residual effects occurred no more frequently with ramelteon at any dose than with placebo. When compared with sleep latency data from a similarly-designed US study, there was no evidence of any ethnic differences in the efficacy of ramelteon between Japanese and US patients. Overall, ramelteon 8 mg showed the most favorable balance between sleep-promoting effects and tolerability. The unique efficacy profile of ramelteon, promoting sleep initiation without affecting other sleep parameters, may be due to its circadian shifting effect.
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PMID:Efficacy and tolerability of ramelteon in a double-blind, placebo-controlled, crossover study in Japanese patients with chronic primary insomnia. 2195 96

Ramelteon is a new class of sleep agent that selectively binds to the melatonin type 1 (MT1) and type 2 (MT2) receptors in the suprachiasmatic nucleus (SCN), instead of binding to GABA-A receptors such as with traditional hypnotics benzodiazepines. Ramelteon exhibits not only acute sleep-promoting effect but also circadian phase-shifting effect via MT1 and MT2 receptors respectively, and has been revealed to contribute to the treatment of acute and chronic insomnia in patients with circadian rhythm sleep disorders(sleep-wake rhythm disorders) or with inappropriate timing of sleep habits. Optimal administration plan for insomniac patients to induce these characteristic sleep-modulating effects by ramelteon was discussed.
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PMID:[New hypnotics ramelteon for the treatment of insomniacs with circadian rhythm disturbance]. 2269 Jun 18

Ramelteon is the first member of a novel class of hypnotics and acts as a selective melatonin receptor agonist. In 2005, ramelteon was approved by the US Food and Drug Administration for the treatment of insomnia characterized by sleep onset problems. Its unique mechanism of action made it a promising candidate compared with the widely used hypnotics that act on the benzodiazepine receptor complex. Several studies have examined its efficacy and safety as a hypnotic agent. The primary efficacy of ramelteon was found to lie in a decrease in latency to persistent sleep, as measured by polysomnographic tests. Other sleep-related measures, such as total sleep time and number of nightly awakenings, show less pronounced improvement when treated with ramelteon. In addition, no rebound insomnia or abuse potential was observed in clinical studies. Although additional studies are necessary, current data on the acute and next-morning effects of ramelteon did not indicate cognitive or psychomotor impairment. Overall, ramelteon is safe and well tolerated, although some questions remain regarding its long-term efficacy and safety. These issues and possibilities for use in other patient groups should be addressed in future research.
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PMID:Critical appraisal of ramelteon in the treatment of insomnia. 2361 13

Ramelteon is a nonscheduled insomnia medication that lacks the abuse potential and residual effects common for other sedative-hypnotics. Distinct in its mechanism, the drug is a melatonin agonist with a high affinity for the membrane receptors MT1 and MT2. Although it therapeutically targets the suprachiasmatic nucleus of the hypothalamus, many organ systems have melatonin receptors and thus may be influenced by ramelteon. A growing body of research on melatonin indicates that it modulates the immune system. Indeed, immune cells have been shown to synthesize and to respond to this compound through receptors including MT1 and MT2. Melatonin's effects are generally immunostimulatory, and there is evidence to suggest that the chemical may potentiate autoimmunty. Here, we describe a case of autoimmune hepatitis that developed in a 50-year-old man after starting ramelteon for insomnia. The temporal association between ramelteon initiation and disease development, as well as the immunomodulatory properties of melatonergic compounds, suggest a role for ramelteon in the etiology of his illness.
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PMID:Autoimmune hepatitis in association with ramelteon. 2363 62

Ramelteon is a tricyclic synthetic analog of melatonin that acts specifically on MT1 and MT2 melatonin receptors. Ramelteon is the first melatonin receptor agonist approved by the Food and Drug Administration (FDA) for the treatment of insomnia characterized by sleep onset difficulties. Ramelteon is both a chronobiotic and a hypnotic that has been shown to promote sleep initiation and maintenance in various preclinical and in clinical trials. The efficacy and safety of ramelteon in patients with chronic insomnia was initially confirmed in short-term placebo-controlled trials. These showed little evidence of next-day residual effects, withdrawal symptoms or rebound insomnia. Other studies indicated that ramelteon lacked abuse potential and had a minimal risk of producing dependence or adverse effects on cognitive or psychomotor performance. A 6-month placebo-controlled international study and a 1-year open-label study in the USA demonstrated that ramelteon was effective and well tolerated. Other potential off-label uses of ramelteon include circadian rhythm sleep disorders such as shift-work and jet lag. At the present time the drug should be cautiously prescribed for short-term treatment only.
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PMID:Pharmacotherapy of insomnia with ramelteon: safety, efficacy and clinical applications. 2386 38

A 68-year-old woman presented with a sudden severe headache, vomiting, and disturbed consciousness. She was admitted to the emergency room. Computed tomography (CT) revealed a hemorrhage in the right temporal lobe. Angiography demonstrated a ruptured aneurysm in the right middle cerebral artery (MCA) and an unruptured aneurysm in the left MCA. The subarachnoid hemorrhage was grade 3 (Hunt and Kosnik classification). Emergency craniotomy, clipping of the ruptured aneurysm and removal of the hematoma were performed. The left hemiparesis improved, and the patient was able to walk. We prescribed triazolam (0.25 mg/day) to treat the patient's insomnia. The unruptured aneurysm was additionally clipped on the 15th hospital day. After the second operation, the patient complained of delirium with restlessness, excitement, disorganized behavior, and sleep disturbance. Treatment with thiapride (150 mg/day) did not improve the delirium. We additionally administered Yi-gan san (7.5 g/day) and switched the triazolam to ramelteon (8 mg/day). The Memorial Delirium Assessment Scale score improved dramatically (from 16 at onset to 5 on day 7 and 1 at two months). Yi-gan san is reported to be effective for the treatment of behavioral and psychological symptoms of dementia. Ramelteon, a melatonin receptor agonist, is implicated in the regulation of the sleep-wake cycle. Ramelteon, unlike other hypnotic drugs, does not cause oversedation, rebound insomnia, withdrawal symptoms or dependence. In addition, we have noted no adverse effects, including oversedation or clinically significant changes in laboratory data, during combination therapy. A combination of ramelteon and Yi-gan san may therefore be beneficial in elderly patients with delirium, especially when there is a risk of oversedation.
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PMID:[A combination of ramelteon and Yi-gan san successfully improved post-surgical delirium in a patient with subarachnoid hemorrhage]. 2404 72

Ramelteon is the first selective melatonin receptor agonist and currently is approved in the United States and Japan for the treatment of insomnia. Our meta-analysis assessed the efficacy and safety of ramelteon for the treatment of insomnia in adults. We included both published and unpublished data from randomized placebo-controlled trials evaluating the efficacy of ramelteon in adults with insomnia in the analysis. Our primary outcomes were sleep quality, subjective sleep latency (sSL), and subjective total sleep time (sTST). Secondary outcomes included latency to persistent sleep (LPS), total sleep time (TST), sleep efficiency (SE), proportion of rapid eye movement (REM) sleep, wakefulness after sleep onset (WASO), subjective WASO, number of nighttime awakenings (NAW), subjective NAW, and adverse events. Thirteen trials involving 5812 patients with insomnia or insomnia symptoms with a mean study duration of 38 days were pooled. Ramelteon was associated with reduced sSL (weighted mean difference [WMD], -4.30 min [95% confidence interval {CI}, -7.01 to -1.58]) and improved sleep quality (standardized mean differences, -0.074 [95% CI, -0.13 to -0.02]) but was not associated with increased sTST. Ramelteon also was associated with improvement in LPS, SE, and TST. The only significant adverse event was somnolence. Short-term use of ramelteon was associated with improvement in some sleep parameters in patients with insomnia, but its clinical impact is small. Long-term trials are needed before solid conclusions can be established.
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PMID:Ramelteon for the treatment of insomnia in adults: a systematic review and meta-analysis. 2465 9

Ramelteon is the only FDA-approved melatonin agonist for treatment of insomnia. It acts on melatonin MT1 and MT2 receptors. We describe a case of a patient who was prescribed ramelteon for insomnia disorder. Shortly after initiation of ramelteon, he described vivid nightmares leading to discontinuation of ramelteon. The nightmares ameliorated with ramelteon discontinuation. Ramelteon is well tolerated with a favorable side-effect profile. No documented cases of nightmares secondary to ramelteon use were found in the literature. The effects of ramelteon on rapid eye movement sleep, the stage of sleep where dreams occur, need to be further explored.
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PMID:Ramelteon-induced nightmares: A case report. 2642 81

Patients with cluster headaches occasionally fail to respond to conventional preventive treatments. We herein report a case of a patient with a cluster headache in which the symptoms were refractory to conventional preventive treatments except for high-dose glucocorticoids. The headache attacks occurred daily while sleeping, thus the patient suffered from insomnia. Ramelteon, a selective melatonin receptor agonist and a member of a new class of insomnia therapies, completely suppressed the attacks during sleep and provided rapid relief from insomnia. This is the first English case report to describe the efficacy of ramelteon as a preventive treatment for cluster headaches.
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PMID:A Cluster Headache Responsive to Ramelteon, a Selective Melatonin MT1/MT2 Receptor Agonist. 2758 May 54

Activation of melatonin receptors protects the heart against ischemia-reperfusion injury. Ramelteon, a clinically used drug for insomnia, acts via activation of melatonin receptors. We investigated whether ramelteon induces acute infarct size reduction by postconditioning. Male Wistar rats were randomized to 6 groups. Hearts were treated with melatonin and ramelteon at the beginning of reperfusion. The melatonin receptor inhibitor luzindole was administered with and without melatonin and ramelteon, respectively. Ramelteon reduced infarct size to the same extent as melatonin. Both effects were completely abolished by luzindole. The results show for the first time that ramelteon induces cardioprotection by postconditioning.
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PMID:Activation of Melatonin Receptors by Ramelteon Induces Cardioprotection by Postconditioning in the Rat Heart. 2976 23


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