Overview of approved psychiatric medications 2008-2023: A systematic review

Objective: The purpose of this systematic review is to enumerate the psychiatric medications approved by the Food and Drug Administration (FDA) over the past 15 years, from 2008 to 2023, and describe their mechanism of action, approved indications, dosing ranges, and adverse effects. Methods: Studies published from 2008 to 2023 were identified from the PubMed database, using the keywords: ‘psychiatric’ OR ‘psychopharm*” AND ‘medic*’ OR ‘pharm*’. An independent focused analysis was conducted, and a consensus was reached on the studies for approved medications to be included in this systematic review. Key findings were derived from the full-text and tables of the selected studies. Results: From 2008-2023, the FDA approved 118 medications including: 26 for Schizophrenia, 12 for Bipolar Disorders, 16 for Depressive Disorders, two for Anxiety Disorders, one for Feeding and Eating disorders, 13 for Sleep-Wake Disorders, five for Sexual Dysfunctions, 16 for Substance Use Disorders, six for Neurocognitive Disorders, and 18 for Neurodevelopmental Disorders (specifically, Attention-Deficit/Hyperactivity Disorder, ADHD), in addition to three for Psychiatric Medication-Related Movement Disorders. It is important to note that 37 out of the 118 medications were New Drug Application (NDA) approvals by the FDA, i.e., they have not been previously approved for another indication. We also noted that nine medications were discontinued by the manufacturer, with no reported safety or effectiveness concerns. Over the past fifteen years, several novel treatment approaches and modalities have been introduced, such as monoclonal antibodies for the treatment of Alzheimer’s Disease, very long-acting injectable antipsychotic drugs, targeting the glutamate neurochemical system for depression and depressive symptoms in other disorders, medications for conditions without any previously approved medicines (e.g., Binge Eating Disorder), and tablets with sensors to monitor treatment adherence. Of note, no new medications were approved from 2008-2023 for: Anxiety Disorders (with the exception of two extended-release preparations of previously approved agents), Obsessive-Compulsive Disorder, Trauma- and Stressor-Related Disorders, Dissociation Disorders, Somatic Symptom Disorders, and Disruptive, Impulse-Control, and Conduct Disorders. Conclusion: Approved psychiatric medications from 2008-2023 show substantial promise in the treatment of psychiatric conditions. More than 100 psychiatric medications were approved over the past 15 years for the major psychiatric conditions including a combination of newly introduced medications and new indications and drug formulations for already approved medications. It behooves psychiatric clinicians to keep up to date with this ever evolving and fast changing field. As the overview article, this manuscript will be followed by in-depth, disorder-based descriptions of approved medications, as well as those currently under development in Phase III.