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Lorazepam order alprazolam (Xanax) and diazepam. The total doses of each medications were calculated as follows: For each drug, the following three variables were calculated, based on the dose that was taken for patient: PATIENTS' SIDE METHOD OF RECEIVING DOSE PATIENTS' SIDE DESCRIPTION A. Dose-limiting (LR) adverse events Drug treatment dose range range: All patients with LGS A: Low dose B: High 1: a. Dose-limiting acute adverse events: b. Adverse events that were severe enough to require discontinuation of treatment (i.e., required hospitalization, prolongation of convalescence, or hospital admission): c. Adverse events associated with the use of medication (i.e., not associated with the medication's mechanism of action): d. Adverse events related to the use of other medications (i.e., not related to those medications other than the medication administered for LGS): e. Adverse events not reported by individual patients because of: (i) Lack of information regarding adverse events. (ii) Confirmation of the clinical encounter that resulted in the adverse event (for example, by medical record review at the time of an outpatient encounter or when hospital administration of medication occurs); or (iii) Confirmation of that information through review hospital or clinical documentation from a subsequent encounter. Patient characteristics Adverse events in each patient had been confirmed in previous encounters with the provider. Patients significant comorbidities, including those with a history of psychosis, had greater likelihood developing a treatment-emergent adverse event. In addition, higher levels of severity the adverse event were associated with greater likelihood of requiring treatment. For example, LGS was associated with higher rates of admission to the inpatient unit. All patients were stratified by comorbidity. The presence of any comorbidities (including mental health diagnoses in addition to the LGS) was not associated with an increased incidence of LGS. Patients reporting psychotic symptoms, who were under the care of same provider, were excluded from the study. Patients reporting severe mood symptoms in addition to the LGS, those in whom mental health disorders were suspected and confirmed during the initial evaluation, and those in whom psychiatric evaluation was performed in another provider (e.g., family, friend) were excluded. All patients were instructed to discontinue the LGS within 24 hours of the initial evaluation and at first follow-up visit. During the first 1 year, a total of 757 patients were randomized and treated with these drugs; of the 602 patients who were randomized to the no-medication arm and who completed a year of follow-up compared with 602 randomized to the medications, 40 patients discontinued treatment because of adverse events and 685 patient lost to follow-up were analysis due study termination. Among the 40 patients who reported adverse events, there were a median of 6 (IQR 5–10) events reported during the year, including following events: 1.7 hospital visits in the medication arm (5 no-medication arm), 1.7 visits to an inpatient unit (3 in the medication arm), 1.0 hospital visits associated with emergency department in the medication arm, and 1.5 psychiatric visits or treatment-directed in the medication arm (IQR 1–4 in all cases). The rate of discontinuation due to adverse events was highest in the no-medication arm (30.1%, range: 8% to 54.8%) ()

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