Abstract Study Objectives To assess long-term efficacy and safety of lemborexant (LEM), a novel dual orexin receptor antagonist, versus placebo in adults with insomnia disorder. Methods This was a 12-month, global, multicenter, randomized, double-blind, parallel-group phase 3 study comprising a 6-month placebo-controlled period (reported here) followed by a 6-month active-treatment-only period (reported separately). A total of 949 participants with insomnia (age ≥18 years) were randomized, received treatment with an oral dose of placebo or LEM (5 mg [LEM5] or 10 mg [LEM10]) and were analyzed. Sleep onset and sleep maintenance endpoints were analyzed from daily electronic sleep diary data. Treatment-emergent adverse events (TEAEs) were monitored throughout the study. Results Decreases from baseline in patient-reported (subjective) sleep onset latency and subjective wake after sleep onset, and increases from baseline in subjective sleep efficiency, were significantly greater with LEM5 and LEM10 versus placebo. Significant benefits over placebo were observed at the end of month 6, and at most time points assessed over the 6-month period, indicating long-term sustained efficacy of LEM. A significantly greater percentage of sleep onset responders and sleep maintenance responders were observed with LEM treatment versus placebo. Participants treated with LEM reported a significant improvement in quality of sleep after 6 months versus placebo. The majority of TEAEs were mild or moderate. There was a low rate of serious TEAEs and no deaths. Conclusions LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated. Clinical trial registration ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39

Adjunctive perampanel (8 and 12 mg/d) significantly improved seizure control in patients with refractory POS. Safety and tolerability were acceptable at daily doses of perampanel 4-12 mg.

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This article describes the theory of the formation of the vacuum phenomenon (VP), the detection of the VP, the different medical causes, the different locations of the presentation of the VP, and the differential diagnoses. In the human body, the cavitation effect is recognized on radiological studies; it is called the VP. The mechanism responsible for the formation of the VP is as follows: if an enclosed tissue space is allowed to expand as a rebound phenomenon after an external impact, the volume within the enclosed space will increase. In the setting of expanding volume, the pressure within the space will decrease. The solubility of the gas in the enclosed space will decrease as the pressure of the space decreases. Decreased solubility allows a gas to leave a solution. Clinically, the pathologies associated with the VP have been reported to mainly include the normal joint motion, degeneration of the intervertebral discs or joints, and trauma. The frequent use of CT for trauma patients and the high spatial resolution of CT images might produce the greatest number of chances to detect the VP in trauma patients. The VP is observed at locations that experience a traumatic impact; thus, an analysis of the VP may be useful for elucidating the mechanism of an injury. When the VP is located in the abdomen, it is important to include perforation of the digestive tract in the differential diagnosis. The presence of the VP in trauma patients does not itself influence the final outcome.