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Drug-Induced Sleep Endoscopy DISE with Target Controlled Infusion TCI and Bispectral Analysis in Obstructive Sleep Apnea

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The Effectiveness of the Safety Communication for Concurrent Benzodiazepine-Opioid Therapy: A Retrospective

Raseel Alroba¹, Ohoud Almadani², Dalal Alqahtani²

¹Saudi Food and Drug Authority, Riyadh, Saudi Arabia. raseelalroba@gmail.com.

Drugs - Real World Outcomes

|March 16, 2026

Abstract

Background:

In 2018, Saudi Food and Drug Authority (SFDA) issued a safety communication concerning the potential risk of respiratory depression related to concurrent use of benzodiazepines and opioids. This study aims to evaluate the impact of this safety communication on clinical practice by examining trends in prescribing both medications concurrently pre- and post-safety communication date.

Methods:

A multicenter retrospective cohort study utilizing data from the Real-world Evidence Research Network comprised adult (≥ 18 years old) users of benzodiazepines and opioids from 2016 throughout 2020. This study employed an interrupted time series analysis using an Autoregressive Integrated Moving Average (ARIMA) model to examine changes in concurrent benzodiazepine and opioid use in Saudi Arabia (SA) before and after the safety communication date. Sensitivity analyses were conducted to assess the reliability of the findings.

Results:

A total of 43,906 episodes of concurrent use of benzodiazepines and opioids were identified for 32,035 patients. Comparing concurrent use of benzodiazepines and opioids pre- and post-safety communication, we observed a slight decrease, from 22.5% (22,846 of 101,538 episodes) to 20.4% (21,096 of 103,409 episodes). The result from our selected model, ARIMA, revealed that the estimated step change was 9.3 in prescriptions (95% CI - 154.5 to 173.2) while the estimated change in slope was - 1.7 prescriptions per month (95% CI - 29.4 to 26.1).

Conclusions:

In this study, we observed no significant changes in frequencies and trends in concurrent prescriptions of benzodiazepines and opioids before and after the safety communication. This highlights the need for continuous assessment of risk minimization strategies in achieving the targeted outcome.

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