Golebiowski, Raphael

Abstract Introduction Studies that have resulted in recent approval of hypnotics for chronic insomnia disorder (CID) have extremely restrictive inclusion criteria. We sought to determine how many patients seen in a sleep medicine clinic would be eligible to participate in these trials in order to assess the generalizability of these findings to clinical populations. Methods Six-hundred and twenty-eight patients were screened to identify 100 patients who were ≥18 years old, had a diagnosis of CID, and were prescribed a hypnotic medication at a sleep medicine clinic in a quaternary level healthcare center. Information regarding age, sex, body mass index, comorbid diagnoses, sleep schedule, medications, alcohol/tobacco/illicit drug use, caffeine intake, as well as Epworth Sleepiness Scale, Generalized Anxiety Disorder-7, Patient Health Questionnaire-9, and Insomnia Severity Index scores were abstracted. These data were compared against the inclusion and exclusion criteria for recent regulatory Phase III trials of orexin receptor antagonists (suvorexant, lemborexant, daridorexant). Results Of the 100 patients with CID (mean age=56.2 years; 57% female), only 3 patients met eligibility criteria for inclusion. A majority of patients (80%) would have been excluded due to a prior/concurrent trial of cognitive behavioral therapy for insomnia. If this criterion was set aside, only 11 patients would have been eligible to participate. The remaining top reasons for potential exclusion from the regulatory trials were: presence of medical comorbidities (36%), daytime napping (33%), and sleep apnea (30%). Conclusion A very small number of patients with CID seen in a clinical setting met eligibility criteria for clinical trials of hypnotic medications resulting in regulatory approval. This substantially limits the generalizability of findings from these trials and restricts our ability to determine the efficacy of these drugs in clinical populations. Future trials should enroll patients with less restrictive criteria to help determine the effectiveness of these medications in real world settings. Support (if any)

Abstract Introduction Sleep disruption and reduced sleep duration are potential triggers and also core symptoms of a manic episode. Our understanding of how sleep duration changes during the course of a manic episode and its potential association with symptom improvement is limited. We examined the natural course of sleep duration and its association with time to discharge and other clinical and demographic factors in patients with mania. Methods This was a retrospective study conducted in patients admitted to an acute care psychiatric unit with a manic episode. Sleep duration was determined based on observer report as logged by nursing staff. Sleep duration at admission and discharge were determined by averaging the total sleep time on day 2/3 of hospitalization and day 3/2 preceding discharge date. We obtained data on possible confounders including antipsychotic (chlorpromazine equivalents), benzodiazepine (diazepam equivalents) and other hypnotic medication doses administered at admission and discharge. We examined the associations between the change in sleep duration from admission to discharge with length of hospitalization and other clinical and demographic characteristics. Results The sample consisted of 35 patients (54.3% male) aged 32 ± 9.96 years with an average length of hospitalization of 20.63 ± 18.62 days. The mean sleep duration on admission was 6.23 ± 1.77 hours and was 7.45 ± 1.49 hours on discharge, with a mean change of 1.23 ± 1.93 hours. The change in sleep duration was positively correlated with length of hospitalization (r=0.42; p=0.01). Other clinical factors including benzodiazepine or antipsychotic dose on admission, age, sex, and use of mood stabilizers were not correlated with the change in sleep duration. Conclusion There was a substantial improvement in the total sleep duration in patients with mania over the course of hospitalization. Overall, the change in sleep duration was only correlated to the length of stay and did not appear to be impacted by other clinical and demographic characteristics. Support (if any):