Association of eszopiclone, zaleplon, or zolpidem with complex sleep behaviors resulting in serious injuries, including death.

PURPOSE: To identify and analyze postmarketing cases of complex sleep behaviors (CSBs) resulting in serious injuries, including death, associated with eszopiclone, zaleplon, or zolpidem (Z-drugs). METHODS: Retrospective analysis of the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from 16 December 1992 through 27 February 2018 and medical literature using PubMed and EMBASE. We used random sampling and descriptive statistics. RESULTS: We identified 66 cases that met inclusion and exclusion criteria, four of which were identified in the medical literature. Twenty cases reported death and 46 cases reported serious injuries in association with CSBs occurring after the use of a Z-drug. Fatal cases described events, such as carbon monoxide poisoning, drowning, falls, hypothermia, motor vehicle collisions, and apparent completed suicide. Nonfatal cases resulting in serious injuries described events, such as accidental overdoses, falls, gunshot wounds, hypothermia, third-degree burns, and self-injuries or suicide attempts. Twenty-two cases reported a previous episode of a CSB while taking a Z-drug prior to the event reported in this case series. CONCLUSIONS: The FAERS and medical literature cases support the need for increased awareness of the consequences that may occur because of CSBs associated with the use of Z-drugs. Therefore, to protect public health, regulatory actions were taken, including adding a Boxed Warning, a Contraindication in patients who have experienced a prior episode of a CSB with a Z-drug, and updating the existing Warnings and Precautions. An FDA Drug Safety Communication was also disseminated to alert healthcare professionals and the public of this potential risk.

Impact of Ketamine Use on Adjunctive Analgesic and Sedative Medications in Critically Ill Trauma Patients.

BACKGROUND: Ketamine may be used to manage pain and agitation that is refractory to what are usually considered traditional agents such as fentanyl, propofol, benzodiazepines, and dexmedetomidine; however, literature describing the use of ketamine continuous infusions for this purpose in critically ill trauma patients is limited. OBJECTIVES: The primary objective of this study was to determine the impact of the initiation of a ketamine continuous infusion on sedative and analgesic use in critically ill trauma patients. Secondary objectives were to identify the patient population in which ketamine was initiated, assess the proportion of time patients were at their goal level of sedation, and determine the dosing patterns of adjunctive sedative agents. METHODS: This single-center retrospective chart review over a 19-month period included critically ill mechanically ventilated adult trauma patients in whom a ketamine continuous infusion was initiated for management of sedation and agitation. Patients who received ketamine for other indications or by the acute pain management service were not included in this evaluation. RESULTS: Thirty-six patients were included in the study. Patients in whom ketamine was initiated tended to be white men with blunt trauma. Overall, the initiation of ketamine was associated with a decrease in the amount of opioids and propofol used and an increase in the amount of ziprasidone and dexmedetomidine needed to achieve the goal Richmond Agitation Sedation Score. When compared with the time period before ketamine initiation, the proportion of time that patients achieved goal sedation was not significantly different after the addition of ketamine. CONCLUSIONS: Although the use of ketamine in critically ill mechanically ventilated adult trauma patients was associated with decreased opioid use, it was also associated with increased use of dexmedetomidine and ziprasidone to achieve and maintain sedation. Further examination of clinical outcomes associated with these differences in drug use in a larger population of trauma patients is warranted before routine use of ketamine for analgesia and sedation can be recommended.