[Appropriate Use and Abuse of Sedative-Hypnotic Drugs].

The incidence of insomnia has been increasing in recent years. In addition, due to the impact of the COVID-19 pandemic, more and more people are experiencing a variety of insomniac problems, including having difficulty in sleep initation, waking up too early, and short sleep duration. Chronic insomnia may seriously affect patients' life and work, increase their risks of developing physical and mental illnesses, and cause crushing social and economic burdens. Sedative-hypnotics, including benzodiazepine agonists, melatonin receptor agonists, orexin receptor antagonists, and antidepressants with hypnotic effects, are widely used to treat most patients suffering from insomnia. However, there is the phenomenon of the non-medical use and abuse of sedative-hypnotic drugs, especially benzodiazepine receptor agonists. The abuse of sedative-hypnotic drugs may lead to mental and physical dependence, cognitive impairment, depression and anxiety, as well as an increased risks of falls and death. Therefore, drug regulatory authorities in China and other countries have issued relevant policies to reinforce regulation. Herein, we reviewed the prevalent use and safety of sedative-hypnotic drugs and proposed suggestions concerning their appropriate use. Both the efficacy and safety of sedative-hypnotic drugs should be carefully considered so that patients suffering from insomnia receive thorough and prompt treatment and the problem of potential abuse of sedative-hypnotic drugs is assessed in an objective and scientific manner. We also hope to provide references for the standardized clinical use of insomnia drugs.

Effectiveness of Xiaoyao capsule on sleep disorders and mood disturbance in patients in recovery from coronavirus disease 2019: a randomized controlled trial.

OBJECTIVE: To study the efficacy of Xiaoyao capsule in improving the clinical symptoms of sleep and mood disorders during recovery from coronavirus disease 2019 (COVID-19). METHODS: The study cohort comprised 200 patients with sleep and mood disorders during recovery from COVID-19. Patients were randomized into the control group and the experimental group in a 1:1 ratio by blocked randomization. The patients received either Xiaoyao capsule (experimental group) or a placebo Xiaoyao capsule (control group) for 2 weeks. The improvements in the Traditional Chinese Medicine (TCM) syndrome scales, total effective rates, and disappearance rates of irritability, anxiety, and poor sleep were compared between the two groups. RESULTS: The TCM syndrome pattern scales, total effective rates, and disappearance rates of irritability, anxiety, and poor sleep did not significantly differ between the experimental group versus the control group in the full analysis set and the per protocol set after 1 and 2 weeks of treatment ( > 0.05). CONCLUSIONS: Xiaoyao capsule do not significantly improve the clinical symptoms of sleep and mood disorders in patients in recovery from COVID-19.

The effect of COVID-19 pandemic on sleep-related problems in adults and elderly citizens: An infodemiology study using relative search volume data.

COVID-19 has had a substantial national impact in South Korea, causing negative psychological responses including sleep-related problems. Literature indicates sleep problems among the general population have been reported to be as high as around 35.7% during the first 8 months of COVID-19. Therefore, the aim of this study was to investigate the impact of COVID-19 pandemic on sleep problems among the general population using relative search volume (RSV) data, and whether there are any differences by age and time periods spanning before and during the pandemic. RSV data was collected from the most commonly used search engine in South Korea, NAVER. Search terms were grouped into 4 categories: insomnia, other sleep disorders, sleeping pills, and sleeping pill side effects. Time points were divided into 4 periods, each 7 months long: 7 months before COVID-19 (T0), first confirmed COVID-19 case to 7 months after (T1), 7 to 14 months (T2), and 14 to 21 months (T3). A 2x4 factorial Analysis of Variance was conducted to investigate main effects and interactions between age and time periods. Main effects and interaction effects of age and time periods were significant for all search term groups. For all search terms, both age groups showed dramatic increase from T0 to T1. In age group 60 or above, RSV continued to increase for other sleep disorders and sleeping pill. Insomnia and sleeping pill side effects showed decreasing trend at T3. In general, sudden increase in RSV after occurrence of COVID-19 followed by slow decline were observed. However, for age group 60 or above, RSV values of other sleep disorders and sleeping pills continued to increase, suggesting slower recovery of psychological impact with increasing age. Overall, the results underscore the importance of implementing preventive measures for monitoring sleep problems during the pandemic, especially in the elderly.

[Pre-pandemic melatonin treatment for sleep disorders and COVID-19 infection. A retrospective cross-sectional study]. / Tratamiento con melatonina pre-pandemia por trastornos del sueño e infección por COVID-19. Estudio de corte transversal, retrospectivo.

INTRODUCTION: Melatonin is a safe medication with multiple uses in sleep medicine for the treatment of circadian rhythm disorders, insomnia, and REM sleep behavior disorder. In view that melatonin has been recommended as an adjuvant treatment in COVID-19 pandemic mainly due to its anti-inflammatory properties, the objective of the present study was to evaluate the history of COVID-19 infection and the requirement of hospitalization in a group of adult patients previously treated with melatonin for various sleep disorders. MATERIAL AND METHODS: This is a retrospective cross-sectional study of data from a closed population of 110 adult patients at a University Hospital treated with melatonin for various sleep disorders, analyzed until the onset of COVID-19 pandemic. Demographic and melatonin-related variables (dose, treatment time) were analyzed and were reevaluated during the pandemic period, by scheduled tele-consultation regarding diagnosis, hospitalization requirements, variables related to COVID-19 infection prior to specific vaccination. Categorical variables were described as relative and absolute frequencies. RESULTS: N = 110 patients. Age range = 40- 96 years (mean = 71 years ± 9.9), older adults > 65 years: N =87 (79,1%). COVID-19 infection was recorded in 15 patients (13.5%) requiring hospitalization in 5 of those infected, only one of them with severe pneumonia. There were no deaths due to COVID-19. There were no differences between infected vs. uninfected in age (p = 0.74), body mass index (p = 0.65) or melatonin dose (p = 0.10).The melatonin dose range was 3-150 mg / day (mean = 46.33 ± 34.1), older adults receiving a mean dose of 50,3 ± 35,6.The 75.5% of the patients were treated for at least 12 months with melatonin. CONCLUSION: We found that 13.5% of patients previously treated with melatonin for various sleep disorders were infected by COVID-19, requiring hospitalization with subsequent medical discharge one third of them. According to national records the lethality rate in older adults in August 2020 was 10.5%. No patient treated with melatonin died for this cause in this sample. We did not find statistically significant differences in terms of indicated melatonin dose, age or body mass index, when comparing those infected with those not infected. The patients in general were mostly older adults, treated with a mean dose greater than 40 mg / day of melatonin for various sleep disorders, mainly for complaints of insomnia, for more than 12 months. The results are consistent with a possible preventive effect of melatonin in the COVID-19 pandemic.

Cognitive Behavioral Therapy and Acceptance and Commitment Therapy for the Discontinuation of Long-Term Benzodiazepine Use in Insomnia and Anxiety Disorders.

Benzodiazepines have proven to be highly effective for treating insomnia and anxiety. Although considered safe when taken for a short period of time, a major risk-benefit dilemma arises in the context of long-term use, relating to addiction, withdrawal symptoms, and potential side effects. For these reasons, benzodiazepines are not recommended for treating chronic sleep disorders, anxiety disorders, nor for people over the age of 65, and withdrawal among long-term users is a public health issue. Indeed, only 5% of patients manage to discontinue using these drugs on their own. Even with the help of a general practitioner, this rate does not exceed 25 to 30% of patients, of which approximately 7% manage to remain drug-free in the long term. Cognitive Behavioral Therapies (CBT) offer a crucial solution to this problem, having been shown to increase abstinence success to 70-80%. This article examines traditional and novel CBT techniques in this regard, such as Acceptance and Commitment Therapy, which address both the underlying condition (insomnia/anxiety) and the substance-related disorder. The theoretical framework and evidence supporting the use of these approaches are reviewed. Finally, current research gaps are discussed, and key research perspectives are proposed.

Design of the National Adaptive Trial for PTSD-related Insomnia (NAP Study), VA Cooperative Study Program (CSP) #2016.

There are currently no validated pharmacotherapies for posttraumatic stress disorder (PTSD)-related insomnia. The purpose of the National Adaptive Trial for PTSD-Related Insomnia (NAP Study) is to efficiently compare to placebo the effects of three insomnia medications with different mechanisms of action that are already prescribed widely to veterans diagnosed with PTSD within U.S. Department of Veterans Affairs (VA) Medical Centers. This study plans to enroll 1224 patients from 34 VA Medical Centers into a 12- week prospective, randomized placebo-controlled clinical trial comparing trazodone, eszopiclone, and gabapentin. The primary outcome measure is insomnia, assessed with the Insomnia Severity Index. A novel aspect of this study is its adaptive design. At the recruitment midpoint, an interim analysis will be conducted to inform a decision to close recruitment to any "futile" arms (i.e. arms where further recruitment is very unlikely to yield a significant result) while maintaining the overall study recruitment target. This step could result in the enrichment of the remaining study arms, enhancing statistical power for the remaining comparisons to placebo. This study will also explore clinical, actigraphic, and biochemical predictors of treatment response that may guide future biomarker development. Lastly, due to the COVID-19 pandemic, this study will allow the consenting process and follow-up visits to be conducted via video or phone contact if in-person meetings are not possible. Overall, this study aims to identify at least one effective pharmacotherapy for PTSD-related insomnia, and, perhaps, to generate definitive negative data to reduce the use of ineffective insomnia medications. NATIONAL CLINICAL TRIAL (NCT) IDENTIFIED NUMBER: NCT03668041.

Insomnia episodes, new-onset pharmacological treatments, and other sleep disturbances during the COVID-19 pandemic: a nationwide cross-sectional study in Brazilian health care professionals.

STUDY OBJECTIVES: To evaluate the impact of the coronavirus disease 2019 (COVID-19) pandemic on insomnia and other sleep disturbances in health care professionals. METHODS: A survey was distributed using social media and organizational emails to Brazilian active health care professionals during the COVID-19 outbreak. We explored potential associated factors including age, sex, occupation, workplace, work hours, income, previous infection with COVID-19, recent/current contact with COVID-19 patients, regional number of incident deaths, anxiety, and burnout. We evaluated new-onset/previous insomnia worsening episodes (primary outcome), new pharmacological treatments, sleep quality, duration, nightmares, and snoring (secondary outcomes). RESULTS: A total of 4,384 health professionals from all regions of the country were included in the analysis (44 ± 12 years, 76% females, 53.8% physicians). Overall, 55.7% were assisting patients with COVID-19, and 9.2% had a previous COVID-19 infection. The primary outcome occurred in 32.9% of respondents in parallel to 13% new pharmacological treatments for insomnia. The sleep quality worsened for 61.4%, while 43.5% and 22.8% reported ≥ 1-hour sleep duration reduction and worsening or new-onset nightmares, respectively. Multivariate analyses showed that age (odds ratio [OR]: 1.008; 95% confidence interval [CI] 1.001-1.015), females (OR: 1.590; 95% CI 1.335-1.900), weight change (decrease: OR: 1.772; 95% CI 1.453-2.161; increase: OR: 1.468; 95% CI 1.249-1.728), prevalent anxiety (OR: 3.414; 95% CI 2.954-3.948), new-onset burnout (OR: 1.761; 95% CI 1.489-2.083), family income reduction > 30% (OR: 1.288; 95% CI 1.069-1.553), and assisting patients with COVID-19 (OR: 1.275; 95% CI 1.081-1.506) were independently associated with new-onset or worsening of previous insomnia episodes. CONCLUSIONS: We observed a huge burden of insomnia episodes and other sleep disturbances in health care professionals during the COVID-19 pandemic. CITATION: Drager LF, Pachito DV, Moreno CRC, et al. Insomnia episodes, new-onset pharmacological treatments, and other sleep disturbances during the COVID-19 pandemic: a nationwide cross-sectional study in Brazilian health care professionals. J Clin Sleep Med. 2022;18(2):373-382.

[Observation of therapeutic effect on coronavirus disease 2019 with insomnia in treatment with baduanjin and auricular point sticking therapy].

OBJECTIVE: To compare the clinical therapeutic effect on coronavirus disease 2019 (COVID-19) with insomnia between the combined treatment of baduanjin and auricular point sticking therapy and the medication with oral estazolam on the base of the conventional treatment. METHODS: A total of 90 patients with COVID-19 accompanied with insomnia were randomly divided into an observation group (45 cases, 3 cases dropped off) and a control group (45 cases). In the observation group, baduanjin, a traditional Chinese fitness activity, was practiced everyday. Besides, auricular point sticking therapy was exerted at ear-shenmen (TF 4), subcortex (AT 4), heart (CO 15), occiput (AT 3), etc. These auricular points were pressed and kneaded three times a day, 30 s at each point each time, consecutively for 12 days. In the control group, estazolam tablets were prescribed for oral administration, 1 mg, once daily, consecutively for 12 days. Before and after treatment, the score of Pittsburgh sleep quality index (PSQI), the score of self-rating anxiety scale (SAS), the score of self-rating depression scale (SDS) and the score of symptoms in traditional Chinese medicine (TCM) were observed in the two groups and the clinical therapeutic effect was evaluated. RESULTS: After treatment, the scores of every item and the total scores in PSQI were all reduced as compared with those before treatment in the two groups (P<0.01). The scores of sleep time and sleep efficiency in the observation group were lower than those in the control group after treatment (P<0.05). SAS scores and SDS scores in the observation group and SAS score in the control group after treatment were all reduced as compared with those before treatment (P<0.01), and SDS score in the observation group was lower than that in the control group (P<0.01). After treatment, in the observation group, the score of each of the symptoms of TCM, i.e. unsound sleep, irritability and hot temper, profuse sputum and sticky feeling in the mouth, bitter taste in the mouth and foul breath, abdominal distention and poor appetite, as well as lassitude was reduced as compared with that before treatment successively (P<0.01), and the scores aforementioned (excepted for the unsound sleep) in the observation group were all lower than the control group (P<0.05). The total effective rates were 83.3% (35/42) in the observation group and 84.4% (38/45) in the control group, without statistical difference in comparison (P>0.05). CONCLUSION: The combined treatment of baduanjin and auricular point sticking therapy improves sleep quality, the conditions of anxiety and depression and the symptoms in TCM for patients of COVID-19 with insomnia. The therapeutic effect of this combined treatment is better than the oral administration of estazolam.

Profile of Somryst Prescription Digital Therapeutic for Chronic Insomnia: Overview of Safety and Efficacy.

Introduction: Prescription digital therapeutics (PDTs) represent a new class of software-based medical devices authorized by the Food and Drug Administration (FDA) to treat disease. Somryst™, the first PDT for treating chronic insomnia, delivers cognitive behavioral therapy for insomnia (CBT-I) via a mobile application. CBT-I is the guideline-recommended, first-line treatment for chronic insomnia, but availability of CBT-I therapists is limited. Somryst addresses this need by providing asynchronous access to CBT-I treatment. As a contactless therapeutic medium, Somryst is also an ideal option when face-to-face therapy is not available or recommended for safety reasons (e.g. because of possible exposure to the SARS-CoV-2 virus). Areas covered: This review summarizes the mechanisms of action and technical features of Somryst, and describes safety and effectiveness data from the randomized trials on which FDA clearance was based. Expert opinion: Somryst demonstrates robust clinical efficacy with a favorable benefit-to-risk profile for treating adults with chronic insomnia. FDA clearance was based on data from 2 clinical trials of the first-generation web-based CBT-I platform Sleep Healthy Using the Internet (SHUTi). Somryst, and PDTs in general, are promising devices to address the need for greater accessibility to effective therapies.

[Evaluation and management of insomnia in clinical practice and in the time of CoViD-19 in Italy: expert consensus and task-force recommendations from five scientific societies]. / Valutazione e trattamento dell'insonnia nella pratica clinica e ai tempi di CoViD-19 in Italia: raccomandazioni del panel di esperti e della task-force integrata di cinque società scientifiche.

Insomnia symptoms might affect about 60% of the Italian population. Insomnia is a "24 hours syndrome" and a risk factor for medical and mental disorders. It should always be assessed and treated in the clinical practice. Cognitive Behavioral Therapy for Insomnia is the first line treatment but its availability in Italy is scarce. Pharmacological options in Italy are: melatonin 2 mg prolonged release that should be the first choice in subjects ≥55 years old and used until 13 weeks; and for a short term use (≤4 weeks) Z-drugs or short-acting benzodiazepines (in subjects <65 years old) or a sedating antidepressant.

Neuropsychological and Functional Impact of COVID-19 on Mild Cognitive Impairment.

We present a case report to showcase that behavioral, cognitive, and functional decline may be associated with COVID-19 stay-home guidance among older adults with pre-existent cognitive impairment. In a functionally independent and physically active older adult with Mild Cognitive Impairment, there was worsening in depression and anxiety symptoms associated with the restrictions of COVID-19. Functional decline was also noted as assessed by Instrumental Activities of Daily Living. We discuss solutions to mitigate the effects of COVID-19 restrictions in this vulnerable population.