“…As secondary outcomes, we analysed additional objective and subjective measures of efficacy (sleep onset latency, wake time after sleep onset, total sleep time, and number of awakenings, evaluated both by polysomnography and by sleep questionnaire or sleep diary), hangover (eg, sedation and reduced alertness during the day) or increased alertness, rebound or withdrawal phenomena, the total number of patients with one specific adverse event, and the total number of patients with serious adverse events as defined by the FDA (appendix pp [29][30]. We categorised common adverse events using Medical Dictionary for Regulatory Activities (MedDRA) and serious adverse events were defined as described by the FDA.…”