Many patients prefer hypnotics to non-drug treatments despite side effects and issues with drug dependence and tolerance because they help reduce sleep latency (SL) and increase total sleep time (TST) at night. Ĭurrently, the prescribed treatment for insomnia primarily involves drug and behavioral treatments, however, they have limitations. The combined direct and indirect costs for insomnia in the United States exceed $100 billion annually. As the most common sleep disorder, insomnia is a substantial burden on healthcare systems and vulnerable patient groups. Owing to its prevalence, the annual loss of quality-adjusted life-years (QALYs) from insomnia appears to be greater than that from other medical and psychiatric conditions, including arthritis, depression, and hypertension. Insomnia has become the second major reason that leads patients to visit neurology clinics, the first one is headaches. Of the Chinese survey respondents, 45.4% reported varying degrees of insomnia. Based on a meta-analysis of China’s population, the prevalence of insomnia was 15%. The prevalence of insomnia disorder is approximately 10–20%, of which approximately 50% have a chronic course. It is a prevalent condition associated with significant morbidity, reduced productivity, increased risk of accidents, and poor quality of life. Insomnia refers to persistent challenges in falling asleep, maintaining sleep, or waking up earlier than the habitual rise time, and is associated with the impairment of daytime functioning despite the opportunity for sufficient sleep duration. Trial registrationĬhinese Clinical Trial Registry () ChiCTR2200058001. If proven effective, NMN supplement can be used as a new treatment for chronic insomnia in the future. This study will provide more evidence on the effects of NMN on improving sleep quality among patients with chronic insomnia. The duration of the clinical trial is 60 days. Subjects are assessed at two time points: baseline and follow-up. Secondary outcomes are the score on the Insomnia Severity Index (ISI) and Epworth Sleeping Scale (ESS), the total sleep time (TST), sleep efficiency (SE), sleep latency, and REM sleep latency to assess sleep quality changes. The primary outcome is the score on the Pittsburgh Sleep Quality Index (PSQI). All subjects are treated by taking NMN or placebo. All subjects are clinical chronic insomnia patients who meet all inclusion criteria. A total of 400 chronic insomnia patients will be allocated 1:1 to the intervention group (treatment with oral NMN 320 mg/day) or control group (treatment with oral placebo). We describe a proposal for a multicenter, patient-assessor-blinded, randomized controlled trial with two parallel arms. MN supplementation is a potential promising new method for the treatment of insomnia, resulting in a rising need for methodological research towards verifying its efficacy. So new treatment method needs to be taken to improve the treatment effect. The treatment of insomnia, which is the most common sleep disorder, includes drug and behavioral treatment, but each treatment measure has its limitations.
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