A Parallel-Group, Blinded, Placebo-Controlled, Randomised, Pragmatic Clinical Trial Investigating the Effect of Temazepam on Objective and Subjective Measures of Sleep in Critically Ill Patients (The DREAM Trial)

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Abstract Rationale: Patients in the Intensive Care Unit (ICU) suffer disturbed sleep and pharmacological sleep aids are frequently prescribed despite a lack of trials supporting their use. The aim of this study was to assess the effect of a benzodiazepine, temazepam, on the duration and quality of sleep in patients in the ICU. Methods: Investigator-initiated, prospective, single-centre, blinded, placebo-controlled, parallel-group, randomised clinical trial. Adult patients whose treating clinician considered that a pharmacological sleep aid was indicated were considered for inclusion. An independent pharmacist prepared the study drug – a weight and age-adjusted dose of enteral temazepam (10-30 mg) or matching placebo. A single dose of the study drug was administered at 21:00 hours. The primary outcome was total sleep time between 21:00-07:00 hours, determined by structured nurse assessment. Secondary outcomes included assessment of sleep quality, independently determined by the bedside nurse and patient using the Richards-Campbell Sleep Questionnaire (RCSQ). Results: Between October 2020 and May 2024, 56 patients received temazepam (n=28) or placebo (n=28), of whom 53 (26 temazepam, 27 placebo) had data available for total sleep time. The baseline characteristics of participants in each group were similar (mean (SD) age: 55.8 (16.7) vs 62.2 (14.6) years; mean (SD) APACHE III score: 64 (19) vs 61 (22), mean (SD) duration of ICU admission 10.1 (11.3) vs 6.6 (7.1) days, invasively ventilated 5 (18%) vs 2 (7%), for temazepam and placebo respectively). The mean (SD) nurse-observed total sleep time was 351 (122) minutes for temazepam and 287 (127) minutes for the placebo; difference = 64 minutes, (95% confidence intervals (CI): -5 to 133); p = 0.07 (Figure 1). An exploratory adjusted multivariable linear model, including sex, patient age, illness severity and days of ICU admission, found a mean difference in sleep duration of 77 minutes (95%CI: 4 to 150; p = 0.04) with temazepam. Data were available for 51 (88%) nurse-completed and 48 (82%) patient-completed RCSQ assessments. There were no significant differences in total RCSQ when assessed by the nurse (56.6 (16.7) vs 48.5 (22.6), p = 0.15) or the patient (49.7 (27.5) vs 50.8 (23.2), p = 0.70). Conclusion: This study observed a mean increase in sleep duration of one hour using structured nursing observation with less optimistic estimates of the effect on sleep quality, especially as perceived by the patient. Further studies may help better establish the utility of temazepam to improve sleep in ICU patients.

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