Efficacy and Safety of 6-Month Nightly Ramelteon Administration in Adults with Chronic Primary Insomnia

Mayer, Geert; Wang-Weigand, Sherry; Roth-Schechter, Barbara F.; Lehmann, R.; Staner, Corinne; Partinen, Markku

doi:10.1093/sleep/32.3.351

Cited by 103 publications

(117 citation statements)

References 43 publications

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“…This indication is supported by self-report and polysomnographic studies showing that sleep onset is hastened along in a dosage range of 4 to 32 mg [59][60][61][62][63][64], although the indicated clinical dose is 8 mg. The incidence or insomnia increases in the elderly, and studies of remelteon have been conducted in elderly primary insomniacs, which show its efficacy in this population [60,61].…”

Section: Efficacymentioning

confidence: 95%

“…The incidence or insomnia increases in the elderly, and studies of remelteon have been conducted in elderly primary insomniacs, which show its efficacy in this population [60,61]. Tolerance to sleep onset-inducing effects did not develop in the 6-to 12-month studies that have been conducted [63,64]. Interestingly, unlike the BzRAs, polysomnographic measures of efficacy show a more robust effect than patient reports.…”

Section: Efficacymentioning

confidence: 99%

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Insomnia Pharmacotherapy

2012

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Summary The benzodiazepine receptor agonists (BzRAs) a melatonin receptor agonist and a histamine antagonist have all been approved as hypnotics. Beyond their differing mechanisms of action, they have differences in pharmacokinetics, and among the BzRAs differences in receptor subtype affinity and formulations, which provides the physician with broad options for tailoring therapy to each patient's specific needs. Consistent with their specific pharmacokinetics and formulations, these Food and Drug Administration-approved hypnotics have been shown to improve sleep with no evidence of tolerance development in long-term use. In addition, emerging data indicate these drugs also improve aspects of daytime function. Their side effects are either associated with the direct sedating effects of the drugs, doses greater than clinical doses, or a combination with alcohol or other sedating drugs. Anxiolytic BzRAs, sedating antidepressants and antipsychotics have been used off-label as hypnotics. However, in the absence of information regarding their dose range for efficacy and safety, their use as hypnotics is ill-advised.

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Section: Efficacymentioning

confidence: 95%

Section: Efficacymentioning

confidence: 99%

Insomnia Pharmacotherapy

2012

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“…O mesmo estudo não identificou potencial para indução de insônia de rebote, sintomas de abstinência, potencial para abuso e/ou dependência, comprometimento cognitivo ou motor, sugerindo ser uma opção terapêutica em pacientes com história prévia de abuso de substâncias e em pacientes idosos 22 .…”

Section: Melatoninérgicos 1) Ramelteonunclassified

Novos sedativos hipnóticos

Sukys-Claudino

Moraes

Tufik

et al. 2010

Rev. Bras. Psiquiatr.

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ResumoNas últimas décadas houve um esforço para o desenvolvimento de hipnóticos mais seguros e eficazes. Zolpidem, zaleplona, zopiclona, eszopiclona (drogas-z) e indiplona são moduladores do receptor GABA-A, os quais agem de forma seletiva na subunidade α1, exibindo, desta forma, mecanismos similares de ação, embora evidências recentes sugiram que a eszopiclona não seja tão seletiva para a subunidade α1 quanto o zolpidem. Ramelteon e tasimelteon são novos agentes crono-hipnóticos seletivos para os receptores de melatonina MT1 e MT2. Por outro lado, nos últimos anos, o consumo de drogas antidepressivas sedativas tem aumentado significativamente no tratamento da insônia. Como droga experimental, a eplivanserina tem sido testada como um potente agonista inverso do subtipo 5-HT 2A da serotonina, com um uso potencial na dificuldade da manutenção do sono. Outro agente farmacológico para o tratamento da insônia é o almorexant, o qual apresenta um novo mecanismo de ação envolvendo antagonismo do sistema hipocretinérgico, desta forma levando à indução do sono. Finalmente, também discutiremos o potencial papel de outras drogas gabaérgicas no tratamento da insônia.Descritores: Hipnóticos e sedativos; Efeitos fisiológicos de drogas; Receptores de melatonina; Antidepressivos; Distúrbios do início e da manutenção do sono AbstractThere has been a search for more effective and safe hypnotic drugs in the last decades. Zolpidem, zaleplon, zopiclone, eszopiclone (the z-drugs) and indiplon are GABA-A modulators which bind selectively α1 subunits, thus, exhibiting similar mechanisms of action, although recent evidence suggests that eszopiclone is not as selective for α1 subunit as zolpidem is. Ramelteon and tasimelteon are new chrono-hypnotic agents, selective for melatonin MT1 and MT2 receptors. On the other hand, the consumption of sedative antidepressant drugs is significantly increasing for the treatment of insomnia, in the last years. As an experimental drug, eplivanserin is being tested as a potent antagonist of serotonin 2-A receptors (ASTAR) with a potential use in sleep maintenance difficulty. Another recent pharmacological agent for insomnia is almorexant, which new mechanism of action involves antagonism of hypocretinergic system, thus inducing sleep. Finally we also discuss the potential role of other gabaergic drugs for insomnia. Descriptors: Hypnotics and sedatives; Physiological effects of drugs; Receptors, melatonin; Antidepressive agents; Sleep initiation and maintenance disordersIntrodução A insônia é, sem dúvida, na atualidade, o distúrbio do sono mais comum, afetando de 10 a 50% da população 1,2 . As conclusões de um consenso do National Institutes of Health (NHI) indicam que quando utilizamos como critério diagnóstico a necessidade de comprometimento ou impacto nas atividades diurnas, a prevalência da insônia cai para cerca de 10% 3 . Estima-se que cerca de 40% dos indivíduos insones apresentem comorbidade psiquiátrica 4 .Desde a década de 50, a psicofarmacologia vem evoluindo no tratamento da insônia em busca ...

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“…Some studies have reported that administration of sleeping pills 30 min before bedtime shortens sleep latency and increases total sleep time. [1][2][3] Numerous studies have defined normal sleep onset latency as less than 30 min, [4][5][6] and clinical practice guidelines for insomnia also state that 30 min is an optimal length of time for sleep latency. 7 In one study, a sleep latency of 31 min was found to be the most defensible quantitative criteria for insomnia.…”

Section: Introductionmentioning

confidence: 99%

Sleeping Pill Administration Time and Patient Subjective Satisfaction

Chung

Youn

et al. 2016

Journal of Clinical Sleep Medicine

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Study Objectives: Taking hypnotic agents 30 min before bedtime is the usual suggested administration time, but some patients report dissatisfaction with their sleeping pills. We investigated whether the timing of sleeping pill administration influences patient subjective satisfaction with these drugs. Methods: One hundred twelve patients with primary insomnia currently taking benzodiazepine or nonbenzodiazepine gamma-aminobutyric acid (GABA) agonists as sleeping pills were selected. The time of administration for their sleeping pills, bedtime, sleep onset time, and wake up time were obtained from their medical records. Subjects were also categorized into satisfied or dissatisfied groups. Results: Hypnotic agents administration time (p < 0.001) and bedtime (p < 0.001), but not sleep onset or wake up time, occurred later in the night in the satisfied group. The durations from administration of pills to sleep onset (33.6 ± 20.7 min) and to wake up time (7.2 ± 1.2 h) were significantly shorter in the satisfied group when compared to the dissatisfied group (135.9 ± 73.4 min and 9.3 ± 1.5 h for time to sleep onset and wake up, respectively). Logistic regression analysis revealed that patient subjective satisfaction with hypnotic agents could be predicted by a short duration from administration of pills to sleep onset (odds ratio = 0.01; 95% confidence interval [0.001-0.09]) and a short duration from administration of pills to wake up time (0.53; [0.31-0.89], F = 49.9, p < 0.001). Conclusions:Taking sleeping pills at a later time and a shorter interval between pill administration and wake up time may increase patient subjective satisfaction with hypnotic agents. We propose that physicians advise patients to take sleeping pills approximately 7 h before their usual getting-out-of-bed time instead of the current standard of 30 min before bedtime.

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Efficacy and Safety of 6-Month Nightly Ramelteon Administration in Adults with Chronic Primary Insomnia

Abstract: In adults with chronic insomnia, long-term ramelteon treatment consistently reduced sleep onset, with no next-morning residual effects or rebound insomnia or withdrawal symptoms upon discontinuation.

Cited by 103 publications

References 43 publications

Insomnia Pharmacotherapy

Insomnia Pharmacotherapy

Novos sedativos hipnóticos

Sleeping Pill Administration Time and Patient Subjective Satisfaction

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