A Polysomnography Study And Assessment Of The Efficacy Of OTC Drug Paracetamol Lamin In The Treatment Of Acute Insomnia In Adults

Objective:This randomized, double-blind, cross-over study assessed the efficacy and impact on sleep structrue of Paracetamol Lamin, a OTC (Over The Counter) hypnotic agent, in adults with acute insomnia by using the polysomnography Examination and rating scale. This is a reference for helping the patients with acute insomnia choosing OTC drugs.Methods:A randomized crossover controlled trial was designed to compare the test drug Paracetamol Lamin and the reference drugs eszopiclone two cycles cross-controlled trial。There are 32 patients with chief complaint of lack of sleep, including 20 women,12 men,with average age of 36.2 years,coming from the Sleep Disorders Clinic at the Department of Neurology, Changzheng Hospital. Second crossover cycle after randomization crossover controlled trial. Second, cross-controlled trial period is divided into two phases. Patients received medication for a stage of 3 days and an intermediate washout period of 2 days. Sleep-related outcomes included objective test (polysomnography), records of patients with total time in bed, total sleep time, awake time, sleep latency, sleep efficiency, NREM sleep time and percentage of each period, REM sleep time and percentage. Use the insomnia severity index scale (ISI), mini-mental state examination (MMSE) to assess the degree of insomnia and impact of drugs on cognitive fuction during the day.Results:Paracetamol Lamin can shorten sleep latency, prolong total sleep time, decrease wake up times, improve sleep efficiency, reduce awake time, decrease light sleep (NREM1 period) the percentage of time, and increase the percentage of slow wave sleep. No effect was observed on the percentage of NREM2 period and REM sleep. Paracetamol Lamin can improve the quality of patient subjective assessment of sleep and presented no obvious effect on cognitive function on first the morning after patients taking the medication. As the treatment extended, the symptoms were further improved, e.g., the subjective assessment and the objective indicators of sleep. There was no significant difference in efficacy between Paracetamol Lamin and eszopiclone.Conclusion:Paracetamol Lamin have positive adjustment to the sleep structure in patients with acute insomnia; patients after taking Paracetamol Lamin improve subjective assessment of sleep quality, and without significant effect on cognitive. Paracetamol Lamin for treatment of acute insomnia patients can get better in the short term, as the only OTC sedative hypnotics, its safety and efficacy should be affirmed.