What’s new in psychiatry

Clozapine REMS is gone · Jun 13, 2025. FDA stopped enforcing the REMS on Feb 24, 2025 and formally eliminated it on June 13, 2025 — any pharmacy can dispense, no enrollment, no ANC reporting to REMS. ANC monitoring still per label; boxed warning stays. ⚖ Contradicts Maudsley 15e’s mandatory-REMS teaching.

→ Lower your threshold for clozapine in treatment-resistant schizophrenia — you still own the blood draws.

Delirium: stop reflexive antipsychotics · APA guideline 2e, Sept 2025. First update in 25 years: do NOT use antipsychotics to prevent delirium or hasten resolution — reserve for severe agitation/psychosis only after de-escalation and reversible-cause workup. ⚖ Contradicts haloperidol-as-mainstay teaching.

→ In the ED: work up the cause first, de-escalate, drug last.

Auvelity (dextromethorphan/bupropion) for Alzheimer’s agitation · Apr 30, 2026. First non-antipsychotic FDA-approved for this indication (brexpiprazole was first overall). 45/105 mg BID after titration — not PRN. Avoids the dementia-mortality boxed warning.

→ New option when antipsychotics are contraindicated or poorly tolerated; screen seizure risk, hypertension, mania history.

Cobenfy (xanomeline/trospium) for schizophrenia · Sept 26, 2024. First muscarinic (M1/M4) antipsychotic — first new mechanism in decades, no dopamine blockade.

→ Consider when metabolic, EPS, or prolactin burden is the problem; main trade-off is GI/cholinergic effects.

Spravato (esketamine) monotherapy for TRD · Jan 21, 2025. No longer requires a concurrent oral antidepressant (REMS clinic logistics unchanged).

→ Offer to patients intolerant of or nonadherent to daily orals.

SSRIs/SNRIs: you must ask about sex · label change, Aug 2026. Sexual dysfunction moved into Warnings & Precautions, Patient Counseling, and the Medication Guide — FDA instructs prescribers to proactively ask. ⚖ Registration-trial rates understated it.

→ Ask about sexual function before starting and during treatment, every patient.

Benzo tapers finally have numbers · joint guideline, June 2025. ASAM-led, 10 societies: 5–10% reduction every 2–4 weeks, never exceed 25% per 2 weeks, hyperbolic (proportional) cuts at low doses; tapers may take months to years.

→ Defensible pacing for every taper conversation.

ADHD stimulant shortage persists into 2026. Adderall (amphetamine/dextroamphetamine), methylphenidate (Ritalin/Concerta), and Vyvanse (lisdexamfetamine) strengths still on back order; the driver is manufacturing concentration (a third of US API from one facility), not just quotas.

→ Expect fill failures; don’t stretch doses without a plan; best-supported nonstimulant is atomoxetine; “dispense as written” + prior auth citing the shortage works.

NY commitment law broadened · effective Aug 7, 2025. “Unable or unwilling to meet essential needs” now counts toward serious harm; psych NPs can sign certificates; Kendra’s Law strengthened.

→ Know the new standard — NY now aligns with 43 other states.

Ketamine in bipolar depression: first RCT, no mania signal · Sept 2026. n=68, serial IV ketamine vs midazolam on a stable mood stabilizer: MADRS −7.3, no mania/hypomania/psychosis. ⚖ Challenges textbook extreme-caution teaching — early evidence, maintenance unresolved.

→ Evidence is shifting; keep monitoring for mania.

Also on the radar: Caplyta (lumateperone) adjunctive MDD (Nov 2025) + relapse-prevention sNDA (Apr 2026) · Bysanti (milsaperidone, iloperidone’s active metabolite) for bipolar mania/schizophrenia (Feb 2026, needs QTc monitoring) · UZEDY (subcutaneous risperidone LAI) monthly for bipolar I maintenance (Oct 2025) · DEA telehealth prescribing waiver through Dec 2026 · MDMA for PTSD got a CRL (not coming soon) · ASCP deprescribing consensus (Mar 2026): reassess every psychotropic yearly, one change at a time.

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