The objective of the present study was to assess the toxicology of melatonin (10 mg), administered for 28 days to 40 volunteers randomly assigned to groups receiving either melatonin (N = 30) or placebo (N = 10) in a double-blind fashion. The following measurements were performed: polysomnography (PSG), laboratory examinations, including complete blood count, urinalysis, sodium, potassium and calcium levels, total protein levels, albumin, blood glucose, triglycerides, total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and very low-density lipoprotein (VLDL), urea, creatinine, uric acid, glutamic-oxalacetic transaminase (GOT), glutamic-pyruvate transaminase (GPT), bilirubin, alkaline phosphatase, gama-glutamic transaminase (GGT), T3, T4, TSH, LH/FSH, cortisol, and melatonin serum concentrations. In addition, the Epworth Somnolence Scale (ESS) and a sleep diary (SD) were also applied to the volunteers 1 wk before each PSG. In addition, the volunteers were asked about possible side effects (SE) that appeared during the treatment. The study was carried out according to the following timetable: Visit 0, filling out the term of consent and inclusion criteria; Visit 1, PSG, laboratory examinations, ESS, SD, melatonin serum concentrations; Visit 2, SD, melatonin serum concentrations, SE; Visit 3, melatonin serum concentrations, PSG, ESS, SE; Visit 4, laboratory examinations, SE, melatonin serum concentrations, SD; and Visit 5, PSG, ESS, SE. Analysis of the PSG showed a statistically significant reduction of stage 1 of sleep in the melatonin group. No other differences between the placebo and melatonin groups were obtained. In the present study we did not observe, according to the parameters analyzed, any toxicological effect that might compromise the use of melatonin at a dose of 10 mg for the period of time utilized in this study.

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Objective: As insomnia is highly prevalent, and side effects of medication are well-known, mind-body interventions are increasingly being sought. The objective of this study is to present a narrative review regarding the effects of mind-body interventions for the treatment of insomnia. Method: A PubMed search was conducted including only randomized, controlled trials in which the main objective was to treat insomnia. Discussion: Twelve studies were selected. In three of the studies, objective parameters (polysomnography) were analyzed. Mind-body interventions were able to improve sleep efficiency and total sleep time. Most can ameliorate sleep quality; some can reduce the use of hypnotic drugs in those who are dependent on these drugs. Conclusion: According to the studies we selected, self-reported sleep was improved by all mind-body treatments, among them yoga, relaxation, Tai Chi Chih and music. Cognitive behavioral therapy seems to be the most effective mind-body intervention. Cognitive behavioral therapy was the only intervention that showed better results than medication. However, considering that only five of the twelve studies chosen reached a score of 3 in the Jadad scale, new studies with a higher methodological quality have to be conducted especially in mind-body interventions that belong to the complementary or alternative medicine field.

The Brazilian Sleep Association brought together specialists in sleep medicine, in order to develop new guidelines on the diagnosis and treatment of insomnias. The following subjects were discussed: concepts, clinical and psychosocial evaluations, recommendations for polysomnography, pharmacological treatment, behavioral and cognitive therapy, comorbidities and insomnia in children. Four levels of evidence were envisaged: standard, recommended, optional and not recommended. For diagnosing of insomnia, psychosocial and polysomnographic investigation were recommended. For non-pharmacological treatment, cognitive behavioral treatment was considered to be standard, while for pharmacological treatment, zolpidem was indicated as the standard drug because of its hypnotic profile, while zopiclone, trazodone and doxepin were recommended. Key words: insomnia, diagnosis of insomnia, treatment of insomnia, cognitive behavioral therapy.Novas diretrizes no diagnóstico e tratamento das insônias resumo A Associação Brasileira de Sono reuniu especialistas em medicina do sono com o objetivo de desenvolver novas diretrizes no diagnóstico e tratamento das insônias. Nós consideramos quatro níveis de evidência: padrão, recomendado, opcional e não recomendado. Os tópicos abordados foram: conceito, avaliação clínica e psicossocial, indicação da polissonografia, tratamento farmacológico, terapia comportamental cognitiva, comorbidades e insônia na infância. Para o diagnóstico da insônia, foi recomendada uma avaliação psicossocial e a realização da polissonografia, enquanto que no que se refere ao tratamento, foi estabelecido como padrão a indicação da terapia comportamental cognitiva, e, quanto ao tratamento farmacológico, foi indicado o uso do zolpidem como hipnótico padrão, e sendo recomendado o zopiclone, a trazodona e a doxepina. Palavras-chave: insônia, diagnóstico da insônia, tratamento da insônia, terapia comportamental cognitiva.