DSM-5-TR: Where Should We Go From Here?

My rite of passage into the world of psychiatry began in 1983 with the purchase of DSM-III for my class on behavioral medicine in medical school. I was impressed at how readable it was, in sharp contrast to many other medical textbooks I had tried to navigate.

The DSM was originally published in 1952, and there have been a series of new editions and revisions since then (Figure). For instance, during my psychiatric internship in 1987, DSM-III-R was published. In it, Robert L. Spitzer, MD, shared the following comment, which has stuck with me since then, as it is timeless in its relevance to any scientific manual¹: “The last sentence of the Introduction to DSM-III, published in 1980, stated ‘...DSM-III is only one still frame in the ongoing process of attempting to better understand mental disorders.’ DSM-III-R represents another still frame.”

Although I am sure the American Psychiatric Association (APA) intended to abide by this ideal, the frames have lost clarity and got stuck from moving forward long ago. For instance, I do not understand why the APA removed the clinically informative 5 axes from the patient diagnostic assessment in DSM-5. And our current DSM-5-TR offered no monumental changes from the previous edition.

Proposing a New Framework

In January 2026, the APA published 5 articles from the Future DSM Strategic Committee detailing the subcommittees’ recommendations, with the qualifier that “the model simply reflects the current state of an evolving discussion and is not intended to be a final product.”^2-6 Awais Aftab, MD, details the highlights in our cover article.

Overall, I found the paper from the Structure and Dimensions Subcommittee most useful for understanding the current recommendations. I read the contextual factors domain with nostalgia, as it reminded me of axes 3, 4, and 5 from DSM-III through DSM-IV-TR. The diagnoses domain is too onerous for me, and I would recommend simply using the most current International Classification of Diseases (ICD) code, which I will discuss further.

Using DSM Diagnoses for Clinical Research

Although not the DSM‘s original intention, when a medication is studied for a specific DSM diagnosis, the resulting medication-diagnosis pairing becomes locked in time, even if the diagnosis disappears from a future DSM.

Take, for example, the indications and usage from the 2014 FDA-approved product insert for hydroxyzine hydrochloride, which is the most up-to-date information, and states it is “for symptomatic relief of anxiety and tension associated with psychoneurosis.”⁷ Yet Psychoneurosis is no longer part of the DSM diagnoses; it is residue from when the brand-name products Atarax and Vistaril were approved by the FDA.

One of my favorite articles captures this quagmire: an exhaustive review of all DSM-IV-TR diagnoses found that 88.2% of DSM-IV-TR diagnoses do not have an FDA-approved medication treatment.⁸ Yet research and expert experience have shown that medications can improve quality of life for those diagnoses. For example, there is no medication approved by the FDA for the treatment of borderline personality disorder (BPD). The current practice is to prescribe a medication that has FDA approval for a diagnosis that shares features of those symptoms. However, insurance companies will often deny coverage because the medications are not specifically approved by the FDA for BPD.

It is unimaginable and inconsistent with competent standard-of-care treatment in medicine for a clinician not to desire to provide a medication to treat a patient in distress because there is no FDA-approved medication for it.

Over my decades of psychiatric practice, I believe that at least 60% of my prescribed medications were technically off-label—or what the FDA calls “unapproved use of an approved”—and this is consistent with conversations I have had with psychiatric colleagues over the years. This is established, ethical medical practice that gets obstructed by formularies and insurance companies that use the off-label status as a justification to deny payment for a medication.

According to standard of care, a medication can be used for unapproved use when published psychiatric literature supports the use of a medication for the diagnosis, competent colleagues would concur it is appropriate treatment, and the patient gives informed consent (which should be documented in the treatment note). The APA released a policy supporting “a physician’s lawful use of an FDA-approved drug product or medical device for an off-label indication.”⁹

However, medication-diagnosis pairings coupled with the lack of FDA-approved medications for DSM diagnoses have created an unethical loophole for insurance companies. A common shared experience among clinicians is to have a prescribed medication denied because the prescribed medication is not approved by the FDA for the patient’s diagnosis, even if the medication has been proven effective.

My most memorable experience involved a 65-year-old patient who, for 14 years, had excellent success with sertraline and ziprasidone for severe obsessive-compulsive disorder (OCD). Medicare denied coverage of the ziprasidone because it was not approved by the FDA for OCD. I appealed their denial through 5 levels of review. The final denial stated, “We agree that the ziprasidone is medically necessary for your patient, however we will not cover it because it is not FDA-approved for OCD.”

Because their position statement strongly supports off-label prescribing and states that all third-party payers should pay for appropriate off-label treatment, my recommendation to the APA is to explicitly include a note in the DSM that a medication-diagnosis pairing from FDA approval is not a requirement for insurance coverage.

A Manual in Constant Evolution Without Reliability

Although it has been acknowledged that the DSM is an “ongoing process of attempting to better understand mental disorders,” it has repeatedly stumbled. For instance, Regier et al¹⁰ described the low reliability levels for DSM-5 major depressive disorder in their publication on the test-retest reliability of selected categorical diagnoses. They stated:

For some common disorders, such as major depressive disorder and generalized anxiety disorder, the marked heterogeneity of patients who meet these diagnostic criteria and their comorbidity with other disorders are associated with lower reliability levels. Greater attempts to improve both the reliability and validity of these diagnoses are called for.

Even the Structure and Dimensions Subcommittee of the Future DSM Strategic Committee admitted²:

Only a minority of patients present with a classic form of one disorder as described in DSM; most instead present with a mixture of problems along dimensions such as mood, anxiety, psychosis, addiction, and so on, to varying degrees.

A Scientifically United Approach for the Future

The DSM is just one part of the current language and dogma used in psychiatry that requires a redesign. Describing a medication as an antidepressant or an antipsychotic is inaccurate and archaic. To reform this, psychopharmacologists created a nomenclature task force in 2008 that included members from 5 well-established nonprofit international neuroscientific organizations. They developed the Neuroscience-based Nomenclature, which names medications based on their mode of action and pharmacological domain.¹¹ So, for example, an antidepressant may be labeled as a serotonin reuptake inhibitor that affects levels of a neurotransmitter.

In my opinion, this is a huge step in the right direction, and this model may inform how we rethink a diagnostic manual for psychiatric disorders. This approach, however, requires input from a diverse range of professions from around the world, which invites the possibility of developing a manual through the World Health Organization (WHO).

The ICD, which is managed and regularly updated by the WHO, is currently the most comprehensive medical and mental health classification resource in the world. The most recent version, ICD-11, was updated with the help of 300 specialists from 55 countries and is used worldwide. Not aligning with their progress and nomenclature is a misstep.

Meanwhile, DSM-5-TR, uses ICD-10 diagnostic codes and is primarily developed by mental health experts in the United States. This siloing of contributors only serves to minimize the DSM’s relevance.

In my opinion, the APA should consider joining the ICD development team at the WHO. This would create a single mental health resource that would reflect the epidemiology of the people of the world, as the ICD-11 currently does for the rest of medicine.

Because the DSM redesign process is in early planning stages, the opportunity exists to take a bold step forward and join the WHO. This would further our evolving understanding of human behavior worldwide, decrease stigma in mental health, and facilitate dialogue on every level.

Dr Miller is Medical Director, Brain Health, Exeter, New Hampshire; Editor in Chief, Psychiatric Times; Volunteer Consulting Psychiatrist, Seacoast Mental Health Center, Exeter; Consulting Psychiatrist, Insight Meditation Society, Barre, Massachusetts.

References

1. DSM-III-R. American Psychiatric Association; 1987.

2. Öngür D, Abi-Dargham A, Clarke DE, et al. The future of DSM: a report from the Structure and Dimensions Subcommittee. Am J Psychiatry. 2026;appiajp20250876.

3. Wainberg ML, Alpert JE, Benton TD, et al. The future of DSM: a strategic vision for incorporating socioeconomic, cultural, and environmental determinants and intersectionality. Am J Psychiatry. 2026;appiajp20250875.

4. Oquendo MA, Abi-Dargham A, Alpert JE, et al. Initial strategy for the future of DSM. Am J Psychiatry. 2026;appiajp20250878.

5. Drexler K, Alpert JE, Benton TD, et al. The future of DSM: are functioning and quality of life essential elements of a complete psychiatric diagnosis? Am J Psychiatry. 2026;appiajp20250874.

6. Cuthbert B, Ajilore O, Alpert JE, et al. The future of DSM: role of candidate biomarkers and biological factors. Am J Psychiatry. 2026;appiajp20250877.

7. Hydroxyzine hydrochloride, USP. Package insert. Teva Pharmaceuticals; 2014. Accessed February 11, 2026. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044lbl.pdf

8. Devulapalli KK, Nasrallah HA. An analysis of the high psychotropic off-label use in psychiatric disorders: the majority of psychiatric diagnoses have no approved drug. Asian J Psychiatr. 2009;2(1):29-36.

9. Position statement on off-label treatments. American Psychiatric Association. 2021. Accessed February 13, 2026. http://www.psychiatry.org/getattachment/053eae03-9e23-422f-ab75-2ea052eb6c81/Position-Off-Label-Treatments.pdf

10. Regier DA, Narrow WE, Clarke DE, et al. DSM-5 field trials in the United States and Canada, part II: test-retest reliability of selected categorical diagnoses. Am J Psychiatry. 2013;170(1):59-70.

11. Zemach S, Zohar J. The importance of proper naming - a review of Neuroscience-based Nomenclature (NbN). Asian J Psychiatr. 2025;103:104317.