A Comprehensive Monograph on Buprenorphine Hydrochloride and Naloxone Hydrochloride for the Treatment of Opioid Use Disorder

Section 1: Introduction and Therapeutic Indication

1.1 Overview and Primary Indication

Buprenorphine hydrochloride and naloxone hydrochloride, most commonly known by the brand name Suboxone®, is a fixed-dose combination medication that has become a cornerstone in the modern management of Opioid Use Disorder (OUD).[1] OUD is a chronic, relapsing neurobiological disease characterized by a powerful, compulsive motivation to obtain and use opioids despite significant and accumulating detrimental consequences to an individual's health, social functioning, professional life, and personal relationships.[1] The United States Food and Drug Administration (FDA) has approved the buprenorphine/naloxone combination product for both the detoxification from opioids and, more critically, for the long-term maintenance therapy of OUD.[1]

It is a fundamental principle of its use that this medication is not a standalone cure but is intended to be prescribed as a component of a comprehensive treatment plan. This integrated approach should include psychosocial support, behavioral therapies, and counseling to address the complex psychological and social dimensions of addiction.[6] In recent years, the clinical and policy lexicon has shifted from "Medication-Assisted Treatment (MAT)" to "Medications for Opioid Use Disorder (MOUD)".[9] This change is not merely semantic; it is a deliberate effort to reframe the role of pharmacotherapy in addiction medicine. The term MAT was seen as implying that medication plays a supplemental or temporary role, a "crutch" to be discarded. The adoption of MOUD aligns the treatment of OUD with that of other chronic medical conditions, such as diabetes or hypertension, where long-term medication is understood to be a primary, often life-sustaining, therapeutic modality.[9] This reframing directly confronts the p