Risk-Benefit Documentation Templates

ACTION: [Start / Continue / Increase / Decrease / Discontinue / Cross-taper / Augment] [Drug Name] [Dose] [Route] [Frequency]. INDICATION: [Primary Diagnosis] — [ICD-10 Code] ([FDA-Approved / Off-Label]). RATIONALE: [Clinical reasoning specific to this patient: why this drug, why this dose, why now]. RISKS DISCUSSED: Discussed risks including [class-specific side effects, black box warnings, drug interactions, monitoring requirements]. BENEFITS: Expected benefits include [specific therapeutic effects]. Benefits of treatment outweigh risks given [patient-specific factors]. PATIENT AGREEMENT: Patient verbalized understanding of risks and benefits, had opportunity to ask questions, questions were answered, and agreed to proceed with treatment plan. [If declined: patient declined — document plan]. ALTERNATIVES DISCUSSED: Alternatives considered: [list]. [Drug chosen] selected because [rationale vs. alternatives]. MONITORING PLAN: [Specific labs, vitals, rating scales, symptom checks, follow-up timeline].

ACTION: Start sertraline [dose] mg PO daily. INDICATION: [Major Depressive Disorder — F32.1 / GAD — F41.1 / Panic Disorder — F41.0 / PTSD — F43.10 / OCD — F42.2] (FDA-Approved). RATIONALE: Sertraline selected given [favorable side effect profile / prior response to SSRIs / cost-effectiveness / clinical presentation consistent with serotonin-mediated depression/anxiety]. First-line antidepressant consistent with APA guidelines. RISKS DISCUSSED: • Activation/agitation: may transiently worsen anxiety in first 1–2 weeks — patient instructed to contact office if severe • GI: nausea (most common, improves within 2 weeks), diarrhea • Sexual dysfunction: decreased libido, delayed orgasm/ejaculation (~30–40%); discuss if patient does not volunteer • Serotonin syndrome: reviewed signs (hyperthermia, tachycardia, clonus, agitation); avoid concurrent serotonergic agents • BLACK BOX: increased suicidality in patients <24 years — discussed explicitly; safety plan reviewed and on file • Discontinuation syndrome if stopped abruptly — must taper when discontinuing • Drug interactions: MAOIs (contraindicated, 14-day washout), triptans, tramadol, linezolid, methylene blue • Onset: 4–6 weeks for full effect; partial response may occur by weeks 2–3 BENEFITS: Expected reduction in [depressive symptoms / anxiety / panic frequency / PTSD hyperarousal]. First-line agent with robust evidence base and favorable tolerability. Benefits of treating [diagnosis] include functional improvement, reduced relapse risk, and improved quality of life. PATIENT AGREEMENT: Patient verbalized understanding of risks and benefits, had opportunity to ask questions, and agreed to proceed. Safety plan reviewed, updated, and signed. Patient instructed NOT to stop medication abruptly. ALTERNATIVES DISCUSSED: SNRIs, bupropion, mirtazapine (sedating), TCA (older, less tolerated), psychotherapy alone or combined. Sertraline chosen due to [evidence base for indication / tolerable side effect profile / patient preference / cost]. MONITORING PLAN: Follow up 2–4 weeks to assess tolerability and early response. PHQ-9 (or GAD-7) at each visit. No routine labs required. If inadequate response at 6–8 weeks at therapeutic dose (≥100–200 mg), reassess diagnosis; consider dose increase or augmentation.

ACTION: Start venlafaxine XR [37.5 / 75] mg PO daily. [Titration plan: increase by 75 mg every 4+ days as tolerated to target dose of ___.] INDICATION: [MDD — F32.1 / GAD — F41.1 / Panic Disorder — F41.0 / Social Anxiety Disorder — F40.10] (FDA-Approved). RATIONALE: Venlafaxine XR selected given [partial SSRI non-response / prominent anxiety component / neuropathic pain comorbidity / evidence for this specific indication]. Dual SNRI mechanism provides broader symptom coverage than SSRI monotherapy for this presentation. RISKS DISCUSSED: • All SSRI-class risks (see above), plus: • Blood pressure: norepinephrine reuptake inhibition can increase BP, particularly at doses >150 mg. Baseline BP: [___]. Will monitor at each visit • Discontinuation syndrome: HIGHEST among antidepressants — "brain zaps," dizziness, nausea, flulike symptoms. NEVER stop abruptly. Taper over minimum 4 weeks; prolonged taper for long-term users. Use XR formulation; pill can be opened and beads counted for fine-taper • Serotonin syndrome: dual mechanism compounds risk — avoid serotonergic combinations • Hyponatremia: elderly patients at risk (SIADH); check sodium if symptoms • BLACK BOX: suicidality <24 years; safety plan reviewed BENEFITS: Dual SNRI mechanism expected to improve [depression / anxiety / somatic symptoms]. Evidence supports efficacy in GAD and MDD when SSRIs are inadequate. PATIENT AGREEMENT: Patient verbalized understanding of risks including blood pressure monitoring need and high discontinuation syndrome risk if stopped abruptly. Agreed NOT to stop medication without medical guidance. Agreed to proceed. ALTERNATIVES DISCUSSED: SSRIs (lower BP risk, milder discontinuation), duloxetine (similar SNRI with FDA approval for pain), desvenlafaxine (active metabolite, less variable pharmacokinetics). MONITORING PLAN: BP at each visit. PHQ-9/GAD-7 at each visit. Reassess dose at 4–6 weeks. If increasing dose above 150 mg, monitor BP more closely.

ACTION: Start bupropion XL [150] mg PO QAM. [Titration: increase to 300 mg after 4 weeks if needed and tolerated.] INDICATION: [MDD — F32.1 / Seasonal Affective Disorder — F33.0 / Smoking Cessation — F17.210] (FDA-Approved). [If ADHD augmentation: Off-Label.] RATIONALE: Bupropion selected given [NDRI mechanism preferred / sexual side effect concern with SSRIs / prominent fatigue/hypersomnia / smoking cessation goal / ADHD comorbidity / patient history]. Does not cause sexual dysfunction — advantage in this patient. RISKS DISCUSSED: • Seizure risk: dose-dependent, approximately 0.1% at ≤450 mg. CONTRAINDICATED in: eating disorders (bulimia/anorexia), history of seizures, abrupt withdrawal from alcohol or benzodiazepines. Patient denies eating disorder; denies seizure history; denies current heavy alcohol use • Activation/agitation: can worsen anxiety or cause insomnia — take before noon; avoid evening dosing • Hypertension: can elevate BP — monitor • No sexual dysfunction: advantage documented for patient with prior SSRI-related sexual side effects • Dry mouth, headache, nausea • Drug interactions: MAOIs (contraindicated); lowers seizure threshold when combined with tramadol, antipsychotics, theophylline • Do NOT exceed 450 mg/day (higher seizure risk); do NOT give as single daily dose >150 mg SR or >450 mg XL BENEFITS: Effective antidepressant with activating properties, smoking cessation benefit, no sexual dysfunction, and minimal weight gain. Expected improvement in energy, motivation, and mood. PATIENT AGREEMENT: Patient denies history of eating disorder, seizures, and active alcohol/benzo dependence. Patient verbalized understanding of seizure risk and instructed not to exceed prescribed dose. Agreed to proceed. ALTERNATIVES DISCUSSED: SSRIs (risk of sexual dysfunction), SNRIs, mirtazapine (sedating, weight gain). MONITORING PLAN: BP at baseline and follow-up visits. PHQ-9 at each visit. Assess for activation/insomnia at 2-week follow-up. Adjust timing or dose if sleep disrupted.

ACTION: Start mirtazapine [7.5 / 15] mg PO QHS. INDICATION: MDD — F32.1 (FDA-Approved). [With comorbid insomnia / poor appetite / nausea — clinically targeted use.] RATIONALE: Mirtazapine selected given [comorbid insomnia / inadequate oral intake / nausea with other antidepressants / need for sedating antidepressant / augmentation of existing SSRI per evidence]. NaSSA mechanism (noradrenergic and specific serotonergic) with minimal GI side effects. RISKS DISCUSSED: • Sedation: prominent, especially at low doses (7.5–15 mg) due to antihistaminergic effect — benefit for insomnia, risk for daytime function • Weight gain: significant — appetite stimulation via H1 and 5-HT2C blockade. Expected weight gain discussed; patient counseled on dietary monitoring • Dry mouth, dizziness • Rare: agranulocytosis (<0.1%) — seek evaluation if fever/sore throat • Lipid effects: may increase cholesterol/triglycerides • No sexual dysfunction (advantage) • Drug interactions: avoid MAOIs; CNS depressants additive (alcohol, benzodiazepines) BENEFITS: Effective antidepressant with rapid sleep benefit, appetite stimulation in underweight patients, and antiemetic properties. Low sexual dysfunction risk. Evidence supports SSRI augmentation (mirtazapine + SSRI "California rocket fuel" strategy). PATIENT AGREEMENT: Patient verbalized understanding of expected weight gain and sedation. Takes QHS for sedation benefit. Agreed to proceed. ALTERNATIVES DISCUSSED: SSRIs (less sedating, weight-neutral), trazodone (lighter sedation option), quetiapine low-dose (sedating but metabolic risk). MONITORING PLAN: Weight at each visit. Lipid panel at 3 months if on long-term. PHQ-9 at each visit. Reassess sleep and appetite at 2–4 weeks.

ACTION: Start trazodone [50 / 100] mg PO QHS. INDICATION: [Insomnia — G47.00 (Off-Label, commonly used) / MDD — F32.1 (FDA-Approved at antidepressant doses 300–600 mg)]. NOTE: At doses ≤150 mg QHS, this is off-label use for insomnia — documented per off-label policy. RATIONALE: Trazodone selected for [non-habit-forming sleep aid / avoidance of scheduled sleep agents / antidepressant augmentation at higher doses]. Serotonin antagonist/reuptake inhibitor (SARI) mechanism. RISKS DISCUSSED: • Sedation/next-day grogginess: antihistaminergic — titrate starting at 50 mg • Orthostatic hypotension: dizziness on standing, fall risk — rise slowly; use caution in elderly • PRIAPISM (males): prolonged painful erection >4 hours. RARE (<1:10,000) but urologic emergency. Patient instructed: go to ER immediately if erection lasts >4 hours. Do NOT ignore • Cardiac: QTc prolongation at higher antidepressant doses — less concern at low sleep doses • Dry mouth, nausea (take with food) • Drug interactions: CYP3A4 inhibitors raise trazodone levels (ketoconazole, ritonavir) BENEFITS: Non-scheduled sleep aid without dependence potential. Effective for sleep onset and maintenance at low doses. Low next-day impairment vs. benzodiazepines. PATIENT AGREEMENT: [Male patients:] Patient verbalized understanding of priapism risk and instructed to seek emergency care if erection persists >4 hours. Patient agreed to proceed. ALTERNATIVES DISCUSSED: Z-drugs (scheduled, habit-forming risk), melatonin/ramelteon (milder effect), mirtazapine (more weight gain), diphenhydramine (rebound, not recommended long-term), CBT-I (first-line, non-pharmacologic). MONITORING PLAN: Sleep quality at 2–4 week follow-up (ISI score or subjective report). BP if elderly. Reassess ongoing need quarterly.

ACTION: Start aripiprazole [2 / 5 / 10] mg PO daily. INDICATION: [MDD adjunct — F32.1 (FDA-Approved augmentation) / Bipolar I — F31.10 (FDA-Approved) / Schizophrenia — F20.9 (FDA-Approved) / Irritability in ASD — F84.0 (FDA-Approved)]. RATIONALE: Aripiprazole selected for [adjunctive antidepressant augmentation per evidence / bipolar maintenance / minimal metabolic burden preferred / activation needed rather than sedation]. RISKS DISCUSSED: • Akathisia: most common EPS — inner restlessness, compulsion to move. Dose-reducible; managed with propranolol, benzodiazepine, or dose reduction. Distinguish from agitation worsening • Activation/insomnia: partial D2 agonism is activating — take in AM; may worsen insomnia • Nausea (usually transient) • Impulse control: rare compulsive behaviors (gambling, eating, hypersexuality) reported • Metabolic: relatively favorable — minimal weight gain and metabolic effect vs. other AAPs • Black box (elderly dementia-related psychosis): increased mortality risk — not indicated for dementia-related psychosis • Tardive dyskinesia: risk increases with duration and cumulative dose BENEFITS: Well-studied augmentation agent for MDD with favorable metabolic profile. Activating properties helpful in fatigue/anhedonia-predominant presentations. PATIENT AGREEMENT: Patient verbalized understanding of akathisia risk and instructed to report restlessness promptly. Elderly status [addressed / not applicable]. Agreed to proceed. ALTERNATIVES DISCUSSED: Quetiapine augmentation (more sedating, higher metabolic risk), brexpiprazole (newer, similar mechanism), lithium/thyroid augmentation. MONITORING PLAN: Metabolic panel, weight, lipids, fasting glucose at baseline and 3 months. AIMS assessment at baseline and annually. PHQ-9 at each visit.

ACTION: Start quetiapine [XR/IR] [25 / 50 / 100 / 150 / 200] mg PO [QHS / BID]. INDICATION: [MDD adjunct — F32.1 (XR, FDA-Approved) / Bipolar I/II — F31.x (FDA-Approved) / GAD — F41.1 (XR, FDA-Approved) / Schizophrenia — F20.9 (FDA-Approved) / Insomnia — G47.00 (Off-Label at low doses)]. RATIONALE: Quetiapine selected for [sedation benefit / bipolar depression efficacy (BOLDER trial) / adjunctive antidepressant augmentation / failed alternatives]. RISKS DISCUSSED: • Metabolic syndrome: weight gain, new-onset diabetes, dyslipidemia — significant risk; monitoring required • Sedation: antihistaminergic effect; next-day grogginess common at higher doses • QTc prolongation: baseline and periodic monitoring; avoid combining with other QTc-prolonging agents • Orthostatic hypotension: rise slowly; fall risk especially at initiation • Cataracts: rare but reported; lens exam if long-term use • Tardive dyskinesia: cumulative dose/duration risk • Black box (dementia-related psychosis, elderly): increased mortality — not indicated for dementia-related behavioral symptoms • Discontinuation: rebound insomnia if stopped abruptly BENEFITS: Effective for [bipolar depression / adjunctive MDD / GAD / sleep maintenance]. Strong evidence for bipolar depression (quetiapine XR, BOLDER I & II trials). Sedation benefit leveraged for sleep in this patient. PATIENT AGREEMENT: Patient verbalized understanding of metabolic monitoring requirements and agreed to labs at [baseline / 3-month follow-up]. Dementia status [addressed / not applicable]. Agreed to proceed. ALTERNATIVES DISCUSSED: Lurasidone (less metabolic burden), aripiprazole (less sedating), lithium (bipolar, renal/thyroid monitoring), lamotrigine (bipolar maintenance, slower titration). MONITORING PLAN: Baseline labs: CMP, lipids, HbA1c, fasting glucose, weight, height, BMI, waist circumference, BP. Repeat at 3 months and annually. AIMS annually. QTc: baseline EKG if clinical indication.

ACTION: Start risperidone [0.5 / 1 / 2] mg PO [daily / BID]. INDICATION: [Schizophrenia — F20.9 / Bipolar I mania — F31.10 / Irritability in ASD — F84.0] (FDA-Approved). [Schizoaffective — F25.0 (FDA-Approved)]. RATIONALE: Risperidone selected for [established efficacy / cost-effectiveness / formulary access / IM formulation available for adherence planning]. Dopamine D2 and serotonin 5-HT2A antagonist. RISKS DISCUSSED: • EPS (most common among AAPs at doses >4 mg): akathisia, parkinsonism, dystonia — managed with dose reduction, anticholinergics (benztropine), or beta-blockers • Prolactin elevation: most pronounced among AAPs — gynecomastia, galactorrhea, menstrual irregularities, sexual dysfunction, osteoporosis with chronic elevation • Metabolic effects: moderate weight gain and metabolic risk (less than olanzapine/clozapine) • QTc: mild prolongation • Tardive dyskinesia: chronic use risk • Black box (dementia-related psychosis, elderly): increased mortality • Sedation, orthostatic hypotension, especially during titration BENEFITS: Well-established antipsychotic with strong evidence across indications. Flexible dosing including IM long-acting injection (Risperdal Consta) for adherence. PATIENT AGREEMENT: Patient verbalized understanding of EPS and prolactin risks. Dementia status addressed. Agreed to proceed. ALTERNATIVES DISCUSSED: Aripiprazole (no prolactin elevation), quetiapine (more sedating), olanzapine (higher metabolic risk). MONITORING PLAN: Weight, BP, metabolic panel at baseline and 3 months. AIMS baseline and annually. Prolactin level if symptoms. EPS assessment at each visit during titration.

ACTION: Start olanzapine [2.5 / 5 / 10] mg PO [daily / QHS]. INDICATION: [Schizophrenia — F20.9 / Bipolar I mania — F31.10 / Bipolar depression (as OFC) — F31.x / MDD adjunct — F32.1] (FDA-Approved). RATIONALE: Olanzapine selected for [acute mania requiring rapid control / refractory psychosis / limited other options / patient history of response / combined olanzapine-fluoxetine (Symbyax) for bipolar depression]. RISKS DISCUSSED: • Metabolic syndrome: HIGHEST metabolic risk among AAPs - Weight gain: average 15–35 lbs; significant weight gain expected and discussed - New-onset diabetes: risk documented; fasting glucose monitoring required - Dyslipidemia: triglycerides and LDL elevation common • Sedation: pronounced antihistaminergic sedation • QTc: mild prolongation • Tardive dyskinesia: long-term risk • Anticholinergic effects: dry mouth, constipation, urinary retention • BLACK BOX: increased mortality in elderly with dementia-related psychosis — NOT indicated for this use • Orthostatic hypotension during titration BENEFITS: Among the most efficacious antipsychotics available. High response rates in acute mania and schizophrenia. Sedation useful in acute agitation contexts. PATIENT AGREEMENT: Patient verbalized understanding of expected significant weight gain and diabetes monitoring requirement. Dietary counseling discussed. Dementia-related use: [not applicable / addressed]. Agreed to proceed. ALTERNATIVES DISCUSSED: Aripiprazole (minimal metabolic effect), lurasidone (low metabolic risk), quetiapine (moderate metabolic risk), ziprasidone (QTc concerns but less metabolic). MONITORING PLAN: Baseline: CMP, fasting glucose, HbA1c, lipid panel, weight, height, BMI, waist circumference, BP. Repeat metabolic panel at 3 months. Annual labs if stable. AIMS baseline and annually. Weight at every visit.

ACTION: Start lurasidone [20 / 40] mg PO daily WITH FOOD (≥350 calories). INDICATION: [Schizophrenia — F20.9 / Bipolar Depression — F31.x] (FDA-Approved). RATIONALE: Lurasidone selected for [bipolar depression with strong evidence base / low metabolic risk preferred / minimal QTc prolongation / once-daily dosing]. Strong evidence from PREVAIL trials for bipolar I and II depression. RISKS DISCUSSED: • Akathisia: most common adverse effect — manage with dose reduction, propranolol, or benzodiazepine • Sedation: moderate; dose at bedtime may improve tolerability • FOOD REQUIREMENT: must be taken with at least 350 calories — bioavailability significantly reduced without food; therapeutic failure may result. Patient instructed and verbalized understanding • Metabolic: favorable profile — minimal weight gain, minimal glucose or lipid effects • Drug interactions: CYP3A4 inhibitors (ketoconazole, grapefruit) significantly raise lurasidone levels — avoid. CYP3A4 inducers (rifampin) reduce levels • QTc: minimal prolongation (advantage) • Nausea: transient, take with food BENEFITS: Effective for bipolar depression and schizophrenia with minimal metabolic burden. Favorable tolerability vs. olanzapine or quetiapine. Preferred in metabolically vulnerable patients. PATIENT AGREEMENT: Patient specifically verbalized understanding that medication must be taken with a meal of at least 350 calories. Agreed to proceed. ALTERNATIVES DISCUSSED: Quetiapine XR (higher metabolic risk), lamotrigine (bipolar depression maintenance, slower titration, no acute effect), lithium (mood stabilizer, renal/thyroid monitoring). MONITORING PLAN: Weight and metabolic panel at baseline. Reassess at 3 months. AIMS annually. PHQ-9/MADRS for bipolar depression tracking.

ACTION: Start lithium carbonate [150 / 300] mg PO [BID / TID]. [Target serum level: 0.8–1.0 mEq/L for acute / 0.6–0.8 mEq/L for maintenance. Will titrate based on levels and response.] INDICATION: Bipolar I Disorder — F31.10 (FDA-Approved: acute mania and maintenance). [Bipolar II — F31.81 / MDD augmentation — F32.x (Off-Label, documented).] RATIONALE: Lithium selected as gold-standard mood stabilizer with [superior antisuicidal evidence / decades of evidence for bipolar maintenance / augmentation strategy for treatment-resistant MDD / patient/family history of lithium response]. RISKS DISCUSSED: • Narrow therapeutic index: serum level monitoring required. Level >1.5 mEq/L = toxicity risk; >2.0 mEq/L = severe toxicity • Toxicity signs: coarse tremor, confusion, ataxia, slurred speech, vomiting, diarrhea → EMERGENCY evaluation immediately. Fine tremor at therapeutic levels is common and expected • Renal effects: chronic use associated with nephrogenic diabetes insipidus (polyuria/polydipsia) and reduced GFR — monitor creatinine/eGFR • Thyroid: hypothyroidism in 20–40% long-term — TSH monitoring required • Cardiac: T-wave changes on EKG (usually benign); arrhythmia at toxic levels • Drug interactions: NSAIDs, thiazide diuretics, ACE inhibitors, ARBs — can raise lithium levels 30–50%; avoid or monitor closely. Metronidazole, tetracyclines also increase levels • Teratogenicity: Ebstein's anomaly (cardiac), Category D. Effective contraception discussed [if applicable] • Hydration: lithium level rises with dehydration (illness, heat, excessive sweating) — maintain adequate fluid intake BENEFITS: Superior to valproate for long-term bipolar maintenance in multiple studies. Antisuicidal properties not replicated by other mood stabilizers (FDA approval for suicide risk reduction in bipolar). Effective as antidepressant augmentation. PATIENT AGREEMENT: Patient verbalized understanding of serum level monitoring requirement, toxicity signs, and when to seek emergency care. NSAID/diuretic interaction discussed. Pregnancy status addressed [if applicable]. Agreed to proceed. ALTERNATIVES DISCUSSED: Valproate (faster onset, less renal/thyroid monitoring but teratogenic), lamotrigine (effective for bipolar depression/maintenance, slower titration), atypical antipsychotics (faster, less monitoring but no antisuicidal data). MONITORING PLAN: Baseline: BMP, Cr/eGFR, TSH, CBC, urinalysis, pregnancy test [if applicable], EKG [if cardiac history]. Serum lithium level: 5–7 days after initiation/dose change, then every 3–6 months when stable. BMP/eGFR: every 6 months. TSH: every 6 months. Level timing: draw 12 hours after last dose (standardized).

ACTION: Start divalproex sodium (Depakote) [250 / 500] mg PO [BID / with meals]. [Target serum level: 50–125 mcg/mL. Titrate based on response and tolerability.] INDICATION: [Bipolar I acute mania — F31.10 (FDA-Approved) / Seizure disorder (adjunct) — G40.x (FDA-Approved) / Migraine prophylaxis — G43.909 (FDA-Approved) / Bipolar maintenance — F31.x (Off-Label)]. RATIONALE: Valproate selected for [acute mania requiring faster onset than lithium / prior response / seizure comorbidity / migraine prophylaxis concurrent benefit]. RISKS DISCUSSED: • TERATOGENICITY (BLACK BOX): neural tube defects (spina bifida) in 1–2% of first-trimester exposures; decreased IQ in exposed children. ABSOLUTELY CONTRAINDICATED in pregnancy except when benefit clearly outweighs risk and no alternatives exist [Women of childbearing age]: Effective contraception REQUIRED. Patient verbalized understanding of pregnancy risk. Contraception: [current method]. Informed of mandatory folic acid supplementation. Signed pregnancy acknowledgment [if clinic policy] • Hepatotoxicity (BLACK BOX): rare but potentially fatal hepatic failure, most common in children <2 years and polytherapy. Monitor LFTs • Pancreatitis (BLACK BOX): acute, potentially fatal. Patient instructed: abdominal pain + nausea = seek care immediately • Thrombocytopenia: CBC monitoring for platelet count • Weight gain and appetite increase • Tremor (dose-related) • Hair loss: alopecia, often reversible; biotin 2.5 mg/day may help • Polycystic ovarian syndrome: association with long-term use in women • Hyperammonemia: can occur without LFT elevation; assess if encephalopathy symptoms BENEFITS: Effective for acute mania with faster onset than lithium. Anticonvulsant and migraine prophylaxis benefits. Good evidence base. PATIENT AGREEMENT: Patient verbalized understanding of hepatotoxicity monitoring need. [Women of childbearing age:] Patient verbalized understanding of teratogenicity risk, confirmed effective contraception, agreed to pregnancy testing before initiation and periodically. Agreed to proceed. ALTERNATIVES DISCUSSED: Lithium (superior antisuicidal data, less teratogenic but requires different monitoring), lamotrigine (preferred for bipolar depression/maintenance, less teratogenic), atypical antipsychotics (no teratogenicity concerns with some agents). MONITORING PLAN: Baseline: CMP, LFTs, CBC with platelets, valproic acid level, ammonia level, pregnancy test [if applicable]. Valproic acid level: 5–7 days after initiation/change (trough — draw before AM dose). LFTs and CBC: monthly x 3 months, then every 6 months. Weight at every visit.

ACTION: Start lamotrigine per slow titration schedule: [Without valproate / enzyme inducers:] Weeks 1–2: 25 mg PO daily Weeks 3–4: 50 mg PO daily Weeks 5–6: 100 mg PO daily Week 7+: 200 mg daily (target; max 400 mg/day) [With valproate (doubles half-life — REDUCE DOSES):] Weeks 1–2: 25 mg PO every other day Weeks 3–4: 25 mg PO daily Weeks 5–6: 50 mg PO daily Week 7+: 100 mg daily (target with valproate) [With enzyme inducer (carbamazepine/phenytoin — reduces half-life — INCREASE DOSES):] Faster titration per package insert. INDICATION: [Bipolar I/II maintenance (depression prevention) — F31.x (FDA-Approved) / Epilepsy — G40.x (FDA-Approved) / Bipolar depression — F31.x (Off-Label, commonly used)]. RATIONALE: Lamotrigine selected for [bipolar depression prevention (superior to lithium for depressive phase) / low teratogenicity compared to valproate / weight-neutral / patient declined or failed alternatives]. RISKS DISCUSSED: • Serious rash / Stevens-Johnson Syndrome (SJS): risk ~0.3–0.8% (higher in children). Risk is DRAMATICALLY REDUCED by slow titration — the prescribed schedule must be followed exactly. Patient instructed: ANY RASH = STOP LAMOTRIGINE AND CALL OFFICE IMMEDIATELY (or ER if severe/spreading/mucous membrane involvement/fever). Do not reassure yourself that it is minor. This is the most important safety instruction Benign rash also occurs — evaluation required to distinguish • Drug interactions: - Valproate DOUBLES lamotrigine levels — dose adjustment as above (MANDATORY) - Oral contraceptives REDUCE lamotrigine levels by ~50% — may need dose increase; watch for toxicity during pill-free week - Carbamazepine/phenytoin REDUCE lamotrigine levels — higher doses needed • Dizziness, diplopia, ataxia at higher doses • Headache, nausea (transient) • Teratogenicity: lower risk than valproate; neural tube risk lower but folate supplementation recommended BENEFITS: Mood stabilizer with strong evidence for bipolar depression prevention. Weight-neutral. Well-tolerated when titrated slowly. PATIENT AGREEMENT: Patient verbalized understanding of SJS rash risk and STOP/CALL instruction for any new rash. Patient confirmed ability to follow titration schedule. Drug interactions [addressed as applicable]. Agreed to proceed. ALTERNATIVES DISCUSSED: Lithium (superior for mania prevention, antisuicidal data), quetiapine XR (bipolar depression FDA-approved, more sedating/metabolic), lurasidone (bipolar depression, less metabolic burden). MONITORING PLAN: No routine serum level monitoring required (levels don't correlate with efficacy). Clinical reassessment at 4–6 weeks. Rash monitoring ongoing — patient to call for any rash. OCP interaction addressed if applicable.

ACTION: Start carbamazepine [100 / 200] mg PO BID. [Target serum level: 4–12 mcg/mL. Titrate by 200 mg/day every 1–2 weeks as tolerated.] INDICATION: [Bipolar I mania — F31.10 (FDA-Approved as Equetro brand) / Trigeminal neuralgia — G50.0 (FDA-Approved) / Seizure — G40.x (FDA-Approved)]. RATIONALE: Carbamazepine selected for [bipolar mania not responsive to lithium/valproate / trigeminal neuralgia / second-line after other mood stabilizers failed]. RISKS DISCUSSED: • HLA-B*1502 genetic variant (patients of Asian ancestry): STRONGLY associated with SJS/TEN. Genetic testing REQUIRED before starting in Asian patients. [Tested: ___. Result: ___. / Testing declined — risk discussed.] • Stevens-Johnson Syndrome: rash protocol — any new rash = stop and evaluate immediately • Hyponatremia (SIADH): sodium monitoring required; avoid in patients on thiazide diuretics or other hyponatremia risks • Drug interactions (strong CYP3A4 inducer and auto-inducer): - Reduces levels of many medications: oral contraceptives, warfarin, antipsychotics, other anticonvulsants, some antibiotics - Auto-induction: reduces its own levels over 3–4 weeks — dose may need adjustment after initiation • Hematologic: agranulocytosis and aplastic anemia — rare but serious. CBC monitoring required. Patient instructed: fever, sore throat, bruising = seek medical evaluation • Hepatotoxicity: LFT monitoring • Teratogenicity: neural tube defects — similar risk to valproate. Contraception counseling [if applicable] • Dizziness, diplopia, ataxia, nausea (especially at initiation) BENEFITS: Effective for acute mania. FDA-approved as Equetro (extended-release) for bipolar. Trigeminal neuralgia treatment of choice. PATIENT AGREEMENT: Asian ancestry: [addressed — testing performed/patient informed / not applicable]. SJS/rash protocol verbalized. Drug interaction with OCP/other medications addressed. Agreed to proceed. ALTERNATIVES DISCUSSED: Lithium, valproate, lamotrigine, atypical antipsychotics. MONITORING PLAN: Baseline: CBC with differential, CMP, LFTs, carbamazepine level, sodium, [HLA-B*1502 if Asian ancestry], pregnancy test [if applicable]. CBC: weekly x 4 months, then every 3–6 months. Serum level (trough): at 4 weeks (after auto-induction stabilizes), then every 6 months. Sodium: every 3–6 months.

ACTION: Start [lorazepam / clonazepam / alprazolam / diazepam] [dose] mg PO [frequency]. INDICATION: [GAD — F41.1 / Panic Disorder — F41.0 / Acute Anxiety — F41.9 / Alcohol Withdrawal — F10.232 / Seizure Prophylaxis — G40.x / Catatonia — F06.1] ([FDA-Approved / Off-Label]). RATIONALE: [Drug] selected for [short-term acute anxiety management / alcohol withdrawal per CIWA-Ar protocol score ___ / catatonia / seizure prophylaxis]. [Short-term use planned: ≤4 weeks] OR [Chronic use discussed with risk-benefit due to: specify clinical need. Non-controlled alternatives tried/considered: see below.] RISKS DISCUSSED (ENHANCED — Schedule IV Controlled Substance): • Physical dependence: develops within 2–4 weeks of daily use — not the same as addiction, but dose cannot be stopped abruptly • Withdrawal: potentially life-threatening if abruptly stopped after physical dependence — severe withdrawal may include seizures. NEVER stop without medical supervision • Tolerance: reduced anxiolytic efficacy with chronic daily use • Cognitive effects: memory impairment, sedation, psychomotor slowing — do NOT drive or operate machinery when sedated • Falls risk: significant in elderly; Beers Criteria 2023 — avoid in ≥65 • Respiratory depression: risk of overdose, particularly with concurrent CNS depressants • BLACK BOX WARNING: concurrent opioid use → profound sedation, respiratory depression, coma, death. [Concurrent opioid use: YES — risks discussed explicitly, naloxone prescribed / NO — patient denies concurrent opioid use] • Diversion potential: patient advised prescription is for personal use only; sharing is illegal; do not report as lost unless genuinely lost (discuss reporting protocol) BENEFITS: [Specific benefit for indication, e.g., acute anxiolysis pending SSRI onset / alcohol withdrawal seizure prophylaxis / acute catatonia management]. PATIENT AGREEMENT: Patient verbalized understanding of physical dependence potential, withdrawal risk, and respiratory depression risk with concurrent CNS depressants. Patient denies concurrent CNS depressant or opioid use [or: concurrent use noted — risk discussed, naloxone prescribed]. Patient agreed to controlled substance agreement (signed [date]). Agreed to proceed. ALTERNATIVES DISCUSSED: SSRIs/SNRIs (first-line for chronic anxiety, 4–6 week onset), buspirone (no dependence, 2–4 week onset), hydroxyzine (non-scheduled, immediate), gabapentin (off-label), propranolol (situational/somatic). [Drug chosen] because [rationale — e.g., acute alcohol withdrawal requiring scheduled benzo per CIWA-Ar protocol]. PDMP REVIEWED: [Date]. [No unexpected controlled substances identified / Unexpected findings: specify — see clinical response]. MONITORING: PDMP and UDS per CS protocol. Re-evaluate clinical need at [4 weeks]. If chronic use anticipated, tapering plan will be developed at __ weeks. Controlled substance agreement on file.

ACTION: Start [mixed amphetamine salts / methylphenidate / lisdexamfetamine / dexmethylphenidate] [dose] mg PO [QAM / BID; last dose no later than 3 PM]. INDICATION: Attention-Deficit/Hyperactivity Disorder — F90.[0 inattentive / 1 hyperactive-impulsive / 2 combined] (FDA-Approved). RATIONALE: DSM-5 criteria for ADHD confirmed via [structured clinical interview / ADHD-RS score ___ / validated self-report scale ___]. Differential diagnoses excluded: [bipolar disorder, anxiety, PTSD, sleep disorder, substance use]. [Drug selected] based on [abuse-deterrent formulation preference / formulary / schedule / prior response / patient preference]. CARDIAC SCREENING (Required): Blood pressure: [___] — within normal limits / elevated — addressed as follows: ___ Heart rate: [___] — within normal limits / elevated EKG: [not clinically indicated / performed — results: ___] Cardiac clearance: [not required / obtained from: ___] RISKS DISCUSSED (ENHANCED — Schedule II Controlled Substance): • Cardiovascular: increased HR and BP. Contraindicated in serious structural cardiac disease, arrhythmia, or uncontrolled hypertension • Growth: may decrease growth velocity in children — height/weight monitoring every 6 months • Appetite suppression and weight loss — take with or after breakfast to reduce appetite suppression • Insomnia: avoid afternoon/evening dosing • Psychiatric: may unmask or exacerbate mania, psychosis, anxiety — monitor closely • Diversion potential: Schedule II stimulants are subject to diversion. Patient advised prescription is for personal use only; sharing/selling is a federal crime • No early refills (Schedule II) — no phone-in refills; paper or EPCS prescription required each month • Substance use history addressed: [none / history of SUD — risk-benefit discussed, abuse-deterrent formulation chosen: ___] BENEFITS: Expected improvement in attention, impulse control, executive function, and functional outcomes in [school / work / daily living]. First-line pharmacotherapy for ADHD with 80% response rate. PATIENT AGREEMENT: Patient verbalized understanding of cardiovascular monitoring, diversion risks, and Schedule II prescribing rules. Controlled substance agreement signed [date]. Agreed to proceed. ALTERNATIVES DISCUSSED: Non-stimulant options discussed: atomoxetine, guanfacine (Intuniv), clonidine (Kapvay), viloxazine (Qelbree). Behavioral therapy as adjunct or alternative for [age group]. Stimulant chosen for [rationale]. PDMP REVIEWED: [Date]. [No unexpected findings / Findings: ___]. MONITORING: BP and HR at each visit. Height/weight every 6 months [pediatric]. ADHD-RS at follow-up visits. PDMP every 3 months. UDS per clinic protocol.

ACTION: Start zolpidem [5 / 10] mg PO QHS PRN sleep. [Women: 5 mg preferred per FDA guidance. Men: 5–10 mg.] INDICATION: Insomnia — G47.00 (FDA-Approved, short-term use). CBT-I DOCUMENTATION: Cognitive behavioral therapy for insomnia (CBT-I) discussed as the first-line treatment for chronic insomnia with superior long-term outcomes vs. pharmacotherapy. Patient [declined / completed without adequate response / offered referral / engaging with app-based CBT-I]. Pharmacotherapy initiated as [short-term bridge / adjunct]. RATIONALE: Zolpidem initiated for short-term insomnia management [≤4 weeks planned]. Preferred over benzodiazepines for sleep-specific indication. RISKS DISCUSSED: • FDA BLACK BOX WARNING (2019): complex sleep behaviors — sleepwalking, sleep-driving, sleep-eating, and other activities while not fully awake. May occur even at first dose. Patient instructed: if any complex sleep behavior occurs → STOP zolpidem immediately and call office • Next-day impairment: residual sedation — do NOT drive the morning after taking, especially at higher doses or in women (lower clearance) • Physical dependence: even with PRN use, nightly use for weeks can cause dependence • Rebound insomnia: worse sleep for 1–3 nights after stopping — expected, not dangerous • Cognitive effects: memory impairment, confusion, especially in elderly • Elderly: Beers Criteria 2023 — avoid or use lowest dose possible in ≥65 due to fall/fracture risk • Take ONLY at bedtime and only when able to sleep 7–8 hours; do NOT take if not planning to sleep • Drug interactions: CNS depressants additive; alcohol contraindicated BENEFITS: Effective for sleep onset. Non-benzodiazepine GABA-A agonist. Less hangover than older sleep agents at appropriate doses. PATIENT AGREEMENT: Patient verbalized understanding of complex sleep behavior black box warning and agreed to stop immediately and call if this occurs. Driving restrictions verbalized. Agreed to proceed. ALTERNATIVES DISCUSSED: Trazodone (non-scheduled), mirtazapine (non-scheduled), ramelteon (non-scheduled, melatonin receptor agonist), melatonin (OTC), doxepin 3–6 mg (FDA-approved for sleep maintenance), CBT-I (first-line non-pharmacologic). PDMP REVIEWED: [Date]. [No unexpected findings]. MONITORING: Reassess sleep at 4 weeks. Planned duration: [≤4 weeks]. If chronic use needed, reassess risk-benefit with extended documentation. Do not exceed 10 mg/dose.

ACTION: Initiate buprenorphine [/naloxone] [2/0.5 / 4/1 / 8/2] mg SL [daily / BID]. [Home induction / Office-based induction. Target dose: ___ mg/day based on response and cravings.] INDICATION: Opioid Use Disorder, Moderate-Severe — F11.20 (FDA-Approved, 21 CFR Part 1306 — DEA X-waiver no longer required as of 2023). CRITERIA CONFIRMED: Patient meets DSM-5 criteria for OUD — [number] of 11 criteria present. COWS score at induction: [___] (mild ≥5, moderate ≥13, moderate-severe ≥25). INDUCTION REQUIREMENTS: Opioid-free period: [≥12–24 hours for short-acting / ≥24–72+ hours for methadone — transition via bridge protocol if applicable] COWS score before first dose: [___] UDS at induction: [positive for: ___ / negative] Naloxone challenge: [performed / not required — COWS ≥8 confirmed] RISKS DISCUSSED: • Precipitated withdrawal: if taken before adequate opioid-free period or insufficient COWS score — severe, immediate withdrawal that cannot be reversed. Patient instructed on timing requirements • Respiratory depression: lower risk than full agonists due to ceiling effect on respiratory depression, but risk increases with concurrent benzodiazepines, alcohol, or CNS depressants • Diversion: Schedule III controlled substance. Buprenorphine films/tablets for personal use only. PDMP monitoring active • Constipation, nausea, headache (transient) • Dental: sublingual formulation associated with dental caries — rinse mouth after each dose, maintain dental hygiene • Dependence: physical dependence will develop — stopping abruptly causes withdrawal; do not abruptly discontinue without medical guidance • Pregnancy: buprenorphine is standard of care in pregnancy — preferred over full agonist or detox. NOWS may occur in neonate — addressable with appropriate management BENEFITS: FDA-approved MAT for OUD. Reduces overdose mortality by 50–65% in clinical studies. Allows functional recovery. Superior to no treatment or detoxification alone for long-term abstinence and survival. PATIENT AGREEMENT: Patient verbalized understanding of precipitated withdrawal risk and timing requirements. Patient agreed to: controlled substance agreement (signed [date]), random UDS, PDMP monitoring, not sharing medication. Agreed to proceed with MAT. ALTERNATIVES DISCUSSED: Extended-release naltrexone (XR-NTX/Vivitrol — requires full opioid-free period 7–14 days), methadone (OTP-based, more intensive structure), buprenorphine alone (without naloxone — for confirmed naloxone allergy or pregnancy), no treatment (highest mortality risk — discussed explicitly). PDMP REVIEWED: [Date]. [No unexpected controlled substances / Findings: ___]. MONITORING: UDS at every visit initially, then per protocol. PDMP every visit. Assess cravings, side effects, adherence at each visit. Dose optimization over first 2–4 weeks. Pill count if indicated by risk stratification. Consider XR buprenorphine (Sublocade) if adherence is a concern.

ACTION: Start naltrexone [50 mg PO daily (oral) / 380 mg IM gluteal monthly (XR-Vivitrol)]. INDICATION: [Alcohol Use Disorder — F10.20 / Opioid Use Disorder — F11.20] (FDA-Approved). OPIOID-FREE PERIOD CONFIRMATION (MANDATORY): Opioid-free period completed: [≥7–10 days for oral opioids / ≥10–14 days for methadone or buprenorphine] UDS at initiation: [negative for opioids — confirmed] [If any uncertainty:] Naloxone challenge performed: [0.8 mg SC — no withdrawal signs at 30 minutes. Proceeded with naltrexone initiation.] COWS score: [≤4 — acceptable to initiate] RATIONALE: Naltrexone selected for [AUD with cravings/heavy drinking / OUD with completed opioid-free period / patient preference for non-opioid MAT / adherence concern — XR formulation chosen]. RISKS DISCUSSED: • Hepatotoxicity (BLACK BOX): dose-dependent hepatocellular injury risk. CONTRAINDICATED in acute hepatitis, hepatic failure, ALT/AST >5x ULN. Use caution at 3–5x ULN • Opioid sensitivity after naltrexone: if opioid analgesia needed (trauma, surgery), increased opioid doses required; risk of overdose if patient tries to overcome the block using high-dose opioids — medical alert card recommended • Precipitated withdrawal: if opioids present at initiation — severe, immediate, unresponsive to naloxone. Opioid-free period CRITICAL • Nausea (most common at initiation — usually resolves) • Injection site reactions (XR): induration, tenderness, nodule common. Rare: abscess, necrosis → contact office • Dysphoria: may reduce pleasurable effects beyond opioid/alcohol (some patients report emotional blunting) • Not a scheduled controlled substance — adherence to medication is voluntary (advantage: no diversion risk) BENEFITS: Reduces craving and reward from alcohol/opioids via mu-opioid receptor blockade. XR formulation ensures 30-day coverage without daily adherence burden. Evidence: COMBINE trial (AUD), Krupitsky 2011 (OUD). PATIENT AGREEMENT: Patient verbalized understanding of hepatotoxicity monitoring and the critical requirement of opioid-free period before initiation. Medical alert card for opioid sensitivity discussed. Agreed to proceed. ALTERNATIVES DISCUSSED: [AUD:] Acamprosate (less craving data, no hepatotoxicity), disulfiram (deterrent, hepatotoxic, requires abstinence). [OUD:] Buprenorphine/naloxone (agonist, daily or injectable), methadone (OTP). MONITORING PLAN: Baseline LFTs. Repeat LFTs at 3 months, 6 months, then annually if stable. Weight. PHQ-9/AUDIT at each visit.

ACTION: Start acamprosate 666 mg (2 tabs × 333 mg) PO TID with meals. [Dose reduce if eGFR 30–50: 333 mg TID. Contraindicated if eGFR <30.] INDICATION: Alcohol Use Disorder — F10.20 (FDA-Approved: maintenance of abstinence in AUD after acute withdrawal). RATIONALE: Acamprosate selected for [AUD maintenance / hepatic disease making naltrexone higher risk / patient preference / combined with naltrexone for dual mechanism]. Modulates GABA/glutamate to reduce protracted abstinence symptoms and craving. RISKS DISCUSSED: • GI effects: diarrhea most common (15%), nausea, vomiting, flatulence — usually transient; take with food • Renal: renally cleared — dose adjustment required for eGFR <50. Baseline eGFR: [___] • No hepatotoxicity (key advantage over naltrexone in patients with hepatic disease) • No significant drug interactions • Suicidality: small signal in clinical trials — monitor for depression and suicidal ideation • Must still avoid alcohol — does not produce disulfiram-like reaction; craving reduction only BENEFITS: Reduces protracted abstinence symptoms and alcohol craving in abstinent patients. Well-tolerated with no hepatotoxicity or abuse potential. Not a controlled substance. Can be combined with naltrexone. PATIENT AGREEMENT: Patient verbalized understanding of dosing (TID with meals) and renal monitoring need. Agreed to proceed. ALTERNATIVES DISCUSSED: Naltrexone (superior craving reduction data but hepatotoxicity risk), disulfiram (deterrent, requires abstinence, hepatotoxic). MONITORING PLAN: eGFR at baseline and annually. AUDIT-C at each visit. Adherence review (TID dosing is challenging — pill organizer recommended).

ACTION: Start gabapentin [100 / 300] mg PO [TID / QHS]. [Titrate as tolerated to target dose ___ mg/day.] INDICATION: [Postherpetic neuralgia — B02.29 (FDA-Approved) / Partial seizures — G40.x (FDA-Approved) / Anxiety — F41.x (Off-Label) / Alcohol Use Disorder adjunct — F10.20 (Off-Label) / Insomnia — G47.00 (Off-Label)]. NOTE: Off-label indications documented per policy. RATIONALE: Gabapentin selected for [neuropathic pain / anxiety augmentation / AUD maintenance / insomnia / adjunct to antidepressant]. [Mechanism: calcium channel alpha-2-delta modulation, reduces neuronal excitability.] RISKS DISCUSSED: • CNS: sedation, dizziness, ataxia, cognitive impairment — common, dose-related, usually improves • Respiratory depression: additive with opioids and CNS depressants. FDA safety communication (2019): increased risk of serious respiratory depression when combined with CNS depressants — reviewed with patient • Weight gain: dose-related, common with chronic use • Misuse potential: increasing recognition of gabapentin misuse, especially in patients with SUD or concurrent opioid use. [Some states: scheduled. Check state-specific scheduling] • Renal clearance: dose reduction required for reduced eGFR. Baseline eGFR: [___] • Peripheral edema • Discontinuation: do not stop abruptly after high-dose chronic use — taper to avoid withdrawal BENEFITS: Effective for neuropathic pain. Useful off-label for anxiety augmentation, AUD maintenance, and sleep. No hepatotoxicity or significant drug interactions beyond CNS depressant additive effects. PATIENT AGREEMENT: Patient verbalized understanding of sedation risk and respiratory depression risk with concurrent CNS depressants. Agreed to proceed. ALTERNATIVES DISCUSSED: [For anxiety:] SSRIs/SNRIs, buspirone, benzodiazepines (higher risk). [For neuropathic pain:] Duloxetine (FDA-approved for DPN), pregabalin, TCAs. MONITORING PLAN: eGFR at baseline. Weight at follow-up. Assess sedation and function at 2–4 weeks. Off-label response assessment: [specify scale or symptom target].

ACTION: Start prazosin [1] mg PO QHS. [Titrate: 1 mg × 3–7 days → 2 mg → 4 mg → up to 15 mg/day as tolerated and clinically needed.] INDICATION: PTSD-associated nightmares — F43.10 (Off-Label — documented per policy). [Hypertension: FDA-Approved — note if applicable.] RATIONALE: Prazosin selected for PTSD-associated nightmares per evidence base (Raskind 2003, 2013; PTSD Handbook 2023). Alpha-1 adrenergic blockade reduces noradrenergic hyperactivation contributing to trauma nightmares and hyperarousal. RISKS DISCUSSED: • Orthostatic hypotension: most significant risk — dizziness, lightheadedness, syncope on standing. CRITICAL: must take at bedtime and rise slowly from bed if waking during night. Fall risk if getting up at night. Baseline standing BP: [___] • First-dose syncope: can occur with first dose — patient instructed to sit/lie down for 1 hour after first dose; have someone present if possible; use bathroom before taking • Reflex tachycardia: compensatory HR increase with BP drop • Headache, drowsiness • Nasal congestion • Rebound hypertension if stopped abruptly (rare with low psychiatric doses) BENEFITS: Evidence-based for PTSD nightmares — improves nightmare frequency and severity, sleep quality, and overall PTSD symptom burden. Non-scheduled, non-habit-forming. PATIENT AGREEMENT: Patient verbalized understanding of orthostatic hypotension risk and first-dose precautions. Instructed to take at bedtime, rise slowly, fall prevention discussed. Agreed to proceed. ALTERNATIVES DISCUSSED: Prazosin is the most evidence-supported pharmacotherapy for PTSD nightmares. Alternatives: image rehearsal therapy (non-pharmacologic), clonidine (less evidence for nightmares), quetiapine low-dose (more sedation, metabolic risk). MONITORING PLAN: BP (sitting and standing) at each visit during titration. Nightmare frequency scale (PCL-5 or CAPS nightmare item) at baseline and follow-up. Assess orthostatic symptoms at each titration step.

ACTION: Start propranolol [10 / 20 / 40] mg PO [PRN 30–60 min before performance situation / daily for chronic anxiety]. [Non-selective beta-blocker.] INDICATION: [Situational/Performance Anxiety — F40.10 (Off-Label) / Essential Tremor — G25.0 (FDA-Approved) / Hypertension — I10 (FDA-Approved) / Migraine prophylaxis — G43.909 (FDA-Approved)]. NOTE: Performance anxiety use is off-label — documented. RATIONALE: Propranolol selected for [somatic anxiety symptoms — palpitations, tremor, blushing / PRN situational use before performance events / adjunct to SSRI for somatic anxiety component]. Peripheral beta blockade reduces somatic manifestations of anxiety without CNS sedation. RISKS DISCUSSED: • CONTRAINDICATIONS — screened and addressed: - Asthma / reactive airway disease: beta-blockade may cause bronchospasm — CONTRAINDICATED. Patient denies asthma ✓ - COPD: use with caution. Patient status: [___] - Decompensated heart failure: avoid. Cardiac status: [___] - Heart block or bradycardia: baseline HR [___]. Avoid if HR <50 or heart block - Diabetes: may mask hypoglycemia signs (tachycardia blunted). Patient diabetes status: [___] • Abrupt discontinuation: do NOT stop abruptly if daily dosing — may precipitate rebound hypertension or angina in cardiac patients. Taper over ≥1–2 weeks if chronic use • Fatigue, dizziness, cold extremities • Depression: may worsen in susceptible patients — monitor BENEFITS: Effective reduction of somatic anxiety symptoms (palpitations, tremor, blushing, sweating) for situational performance anxiety. Non-sedating. No dependence potential. Not scheduled. PATIENT AGREEMENT: Patient denies asthma, reactive airway disease, heart failure, significant bradycardia, and diabetes. Agreed to proceed. ALTERNATIVES DISCUSSED: Benzodiazepines (scheduled, sedating, dependence potential), hydroxyzine (sedating but non-scheduled), CBT for performance anxiety (gold standard long-term). MONITORING PLAN: BP and HR at each visit if daily dosing. Assess anxiety symptoms and side effects at follow-up.

ACTION: Start hydroxyzine [pamoate (Vistaril) / HCl (Atarax)] [25 / 50] mg PO [PRN anxiety / TID-QID ATC / QHS for sleep]. INDICATION: [Anxiety — F41.1 (FDA-Approved) / Pruritus — L29.9 (FDA-Approved) / Insomnia — G47.00 (Off-Label, PRN use)]. RATIONALE: Hydroxyzine selected as [non-scheduled anxiolytic / first-line in patients with SUD or high diversion risk / adjunct for acute anxiety while awaiting SSRI onset / sleep aid without scheduled medication risk]. Antihistaminergic (H1) + anticholinergic mechanism. RISKS DISCUSSED: • Sedation: significant antihistaminergic sedation — advantage for anxiety/sleep, risk for daytime function. Do NOT drive or operate machinery when sedated • QTc prolongation: mild — avoid combining with other QTc-prolonging agents; not recommended in patients with known QTc prolongation • Anticholinergic effects: dry mouth, constipation, urinary retention, blurred vision — particularly in elderly • Elderly: Beers Criteria consideration — anticholinergic burden in ≥65; use lowest effective dose • Tolerance: antihistaminergic tolerance may develop with daily use (sedative effect diminishes) • No dependence or withdrawal BENEFITS: Effective for acute anxiety with immediate onset (30–60 minutes). Not a controlled substance — no diversion risk, no PDMP requirement. No physical dependence. Safe in SUD population. PATIENT AGREEMENT: Patient verbalized understanding of sedation risk and driving restriction. Agreed to proceed. ALTERNATIVES DISCUSSED: Benzodiazepines (faster onset, higher risk), buspirone (non-sedating, 2–4 week onset), SSRIs/SNRIs (long-term first-line). MONITORING PLAN: Assess anxiety at 2–4 weeks. If using for insomnia, review sleep at follow-up. No labs required for standard use.

ACTION: Start buspirone [7.5 / 10] mg PO BID. [Titrate: increase by 5 mg every 2–3 days as tolerated. Usual effective dose: 20–30 mg/day divided BID-TID. Maximum: 60 mg/day.] INDICATION: Generalized Anxiety Disorder — F41.1 (FDA-Approved). RATIONALE: Buspirone selected for [non-scheduled anxiolytic preferred / patient with SUD making benzodiazepines higher risk / no dependence potential needed / adjunct to SSRI]. Partial 5-HT1A agonist and D2 partial agonist. RISKS DISCUSSED: • ONSET: 2–4 weeks for full anxiolytic effect — no immediate effect. Patient explicitly counseled: "You will NOT feel it working right away. This is normal. Do not stop thinking it doesn't work until 4 weeks." This is critical to adherence • Cannot be used PRN — must be taken consistently BID/TID for effect • Dizziness, nausea, headache (usually transient at initiation) • No sedation (advantage vs. hydroxyzine/benzodiazepines) • No interaction with alcohol (advantage) • No dependence or withdrawal (major advantage) • Less effective if patient has prior chronic benzodiazepine use (sensitized receptors respond less) • MAOIs: contraindicated combination BENEFITS: Effective non-scheduled anxiolytic for GAD. No dependence, no sedation, no alcohol interaction. Safe long-term. Ideal for GAD in SUD population or where benzodiazepines are contraindicated. PATIENT AGREEMENT: Patient verbalized understanding of 2–4 week onset and the requirement for consistent BID dosing. Agreed NOT to evaluate effectiveness until 4 weeks. Agreed to proceed. ALTERNATIVES DISCUSSED: SSRIs/SNRIs (first-line for GAD, once-daily, same 4–6 week onset), hydroxyzine (immediate effect, non-scheduled, sedating), benzodiazepines (immediate, scheduled, dependence risk). MONITORING PLAN: GAD-7 at baseline and 4-week follow-up. Assess tolerability at 2 weeks. Dose titration over 2–3 weeks to therapeutic range.

ACTION: Continue [Drug] [Dose] PO [Frequency] — unchanged. INDICATION: [Diagnosis] — [ICD-10]. ([FDA-Approved / Off-Label]). RESPONSE TO TREATMENT: Patient reports [% improvement / symptom improvement / PHQ-9: ___ (previous ___) / GAD-7: ___ / functional gains: ___]. Tolerating current dose without significant adverse effects [or: side effect ___ noted — managed by ___]. RISK/BENEFIT REVIEW: Risks reviewed today — unchanged from prior documentation [or: new risk identified: ___]. Benefits of continued treatment include [symptom control / relapse prevention / functional maintenance]. Risk of discontinuation at this time outweighs current medication risks. PATIENT AGREEMENT: Patient elects to continue current treatment. No new concerns raised. Questions answered. MONITORING: [Current monitoring plan continues]. Next labs: [date/type]. Next reassessment: [timeframe].

ACTION: Increase [Drug] from [current dose] mg to [new dose] mg [route] [frequency]. INDICATION: [Diagnosis] — [ICD-10]. RATIONALE FOR INCREASE: Partial response to current dose after adequate trial ([duration] weeks at [current dose]). Current symptom scale: [PHQ-9/GAD-7/etc: ___]. Tolerating current dose without significant adverse effects. [New dose] is within the recommended therapeutic dose range ([cite range]: ___). Dose increase is evidence-based next step before considering augmentation or switch. RISKS OF DOSE INCREASE: Dose-related adverse effects may increase — specifically [list dose-dependent side effects for this drug class, e.g., nausea for SSRIs at higher doses, seizure risk for bupropion, BP elevation for venlafaxine]. Risk-benefit ratio remains favorable given partial response and good tolerability. BENEFITS: Evidence supports dose-response relationship for this agent. Expected improvement in [symptoms] with dose optimization before requiring medication change. PATIENT AGREEMENT: Patient understands rationale for dose increase and dose-dependent side effect monitoring. Agrees to increased dose and follow-up. MONITORING: [Adjust monitoring if dose-dependent labs/vitals required]. Follow-up in [2–4 weeks] to assess response and tolerability at new dose.

ACTION: Decrease [Drug] from [current dose] mg to [new dose] mg [route] [frequency]. [This is step ___ of ___ planned taper steps.] RATIONALE: [Adverse effects intolerable at current dose: specify / Patient is in sustained remission and requests trial of lower dose / Preparing for discontinuation / Drug interaction requiring dose reduction: specify / Clinical response warrants lower maintenance dose]. TAPER PLAN: - Current: [dose] - Step 1 (today): [dose] - Step 2 ([date/timeframe]): [dose] - Step 3 ([date/timeframe]): [dose if applicable] - Completion: [anticipated date/timeframe] DISCONTINUATION SYNDROME RISK: [None / Low / Moderate / High] for [drug/class]. [High risk classes: SSRIs (especially paroxetine, venlafaxine), benzodiazepines, stimulants] Patient educated on potential discontinuation symptoms for this class: [SSRI/SNRI: brain zaps, dizziness, irritability, flu-like symptoms] [Benzo: anxiety rebound, insomnia, potentially seizures — NEVER abrupt stop] [Antipsychotic: rebound psychosis, cholinergic rebound, insomnia] [Stimulant: fatigue, hypersomnia, dysphoria — "crash"] Instructed to contact office if discontinuation symptoms emerge; do not stop taper without guidance. SYMPTOM MONITORING: Watch for return of [original diagnosis symptoms] during taper. [Hold taper / return to prior dose] if significant symptom return. PATIENT AGREEMENT: Patient understands taper schedule and discontinuation syndrome risk. Agrees to contact office rather than stopping on own. Agreed to proceed with taper. MONITORING: Follow up in [2–4 weeks] at each taper step to assess tolerability and symptom status.

ACTION: Cross-taper [Drug A] [current dose] → [Drug B] [starting dose] over [timeframe]. RATIONALE FOR SWITCH: [Inadequate response to Drug A after adequate trial: __ months at __ mg / Intolerable adverse effects from Drug A: specify / Patient preference / Drug interaction with new medication / Cost-insurance change / Pregnancy-safety concern]. CROSS-TAPER SCHEDULE: Weeks 1–2: [Drug A] [dose] + [Drug B] [starting dose] Weeks 3–4: [Drug A] [lower dose] + [Drug B] [increased dose] Week 5+: [Drug A] discontinued; [Drug B] [target dose] [Alternatively: direct switch (wash out Drug A before starting Drug B — document rationale)] RISKS OF CROSS-TAPER: • Serotonin syndrome if both are serotonergic agents — monitor for: [hyperthermia, tachycardia, clonus, agitation, diaphoresis] • Drug interaction during overlap period: [specify] • QTc risk if both QTc-prolonging: EKG planned • Temporary symptom worsening possible during transition period • Discontinuation effects from [Drug A] during taper: inform patient PATIENT AGREEMENT: Patient understands the switch rationale and overlap period. Instructed to report symptoms of [serotonin syndrome / discontinuation effects / clinical worsening]. Agreed to proceed. MONITORING: Follow up in 2 weeks to assess tolerability of transition. Reassess full efficacy of [Drug B] at [4–8 weeks] at target dose.

ACTION: Add [Augmenting Drug] [dose] [route] [frequency] to existing [Primary Drug] [dose] regimen. INDICATION FOR AUGMENTATION: Partial response to [Primary Drug] after [duration] at adequate dose [__ mg]. [PHQ-9/scale: current ___]. Prior to augmentation, diagnosis re-confirmed and adherence verified. EVIDENCE BASIS: [Trial/guideline supporting this augmentation strategy, e.g., STAR*D trial — aripiprazole augmentation for TRD; APA guidelines — lithium augmentation for MDD]. RISKS OF AUGMENTATION: • Drug interaction between [Primary Drug] and [Augmenter]: [specify if any — or "no clinically significant pharmacokinetic interaction anticipated"] • Additive side effects: [list by class] • Additional monitoring requirements: [labs/vitals/scale] • Polypharmacy risk: additional medication burden discussed BENEFITS: Evidence supports [X%] additional response with this augmentation strategy. Expected to achieve further improvement in [symptoms] without switching away from partially effective [Primary Drug]. PATIENT AGREEMENT: Patient understands rationale for adding a second medication and associated monitoring. Agreed to proceed. MONITORING: Reassess augmentation effect at [4–8 weeks]. If no additional benefit after adequate trial, consider alternative augmentation strategy or medication switch. [Specific monitoring for augmenting agent: see standard template for that drug class].

ACTION: Discontinue [Drug] [dose]. [Tapering over [timeframe] / Abrupt discontinuation — rationale: ___.] RATIONALE FOR DISCONTINUATION: [Adequate treatment course completed — criteria for discontinuation met / Intolerable adverse effects despite dose adjustment / Lack of efficacy after adequate trial: __ months at adequate dose / Patient-initiated request after informed discussion / Clinical indication resolved / Preparing for pregnancy / Drug interaction requiring discontinuation]. TAPER PLAN: [Specific taper schedule — see dose decrease template above / Not required for this class at this dose and duration]. DISCONTINUATION SYNDROME RISK: [Class-specific risk level and expected timeline]. Patient educated on discontinuation symptoms: [class-specific — e.g., SSRI: "brain zaps," dizziness, nausea, flu-like; benzodiazepine: anxiety, seizure risk; opioids: flu-like withdrawal]. Instructed to contact office for severe or unexpected symptoms. RETURN OF SYMPTOMS: Discussed risk of [condition] returning after discontinuation. [Relapse risk: low / moderate / high given ___ features]. Patient understands and accepts this risk. Relapse prevention plan: [therapy / social support / crisis contacts / restart plan if needed]. SAFETY REVIEW AT DISCONTINUATION: PHQ-9: [score]. GAD-7 [if applicable]: [score]. SI: [denied / plan addressed]. Safety plan: [current / updated]. PATIENT AGREEMENT: Patient understands the discontinuation plan, withdrawal risk, and relapse prevention approach. Agreed to follow taper schedule if applicable. MONITORING: Follow up [2–4 weeks] after discontinuation to assess for withdrawal symptoms and return of primary condition. PRN contact for symptom emergence encouraged.

ACTION: Start [Drug] [dose] [route] [frequency] for OFF-LABEL use. INDICATION: [Diagnosis] — [ICD-10]. NOTE: This use is OFF-LABEL. FDA has not approved [Drug] for this indication. OFF-LABEL DOCUMENTATION: This medication is being used off-label based on the following evidence: [ ] Published randomized controlled trial: [cite author, year, journal] [ ] Systematic review / meta-analysis: [cite] [ ] Clinical practice guideline recommendation: [cite organization, year] [ ] Expert consensus or case series: [cite] [ ] Reasonable mechanistic extrapolation from approved indication Standard of care basis: [Brief statement of why this is acceptable clinical practice, e.g., "Off-label use of prazosin for PTSD nightmares is supported by multiple RCTs and recommended by the VA/DoD PTSD Clinical Practice Guideline (2023)."] RISKS DISCUSSED: All standard risks for [drug class] apply (see above). Additionally: patient was explicitly informed this is an off-label use, meaning: • FDA has not formally reviewed or approved this specific use • Evidence may be more limited than for FDA-approved indications • Insurance coverage may not be guaranteed Patient verbalized understanding of off-label status and agreed to proceed. BENEFITS: [Expected therapeutic effect based on available evidence]. Off-label benefit expected to outweigh risks based on [evidence summary]. ALTERNATIVES DISCUSSED: FDA-approved treatments for [diagnosis] considered: [list]. Off-label agent chosen because [rationale — e.g., "first-line agents failed / contraindicated / patient declined / clinical profile more suited to this agent"]. PATIENT AGREEMENT: Patient specifically informed this is an off-label use of [drug]. Patient understood and agreed to proceed. MONITORING: [Define success criteria — specific endpoint or symptom target]. Re-evaluate at [timeframe]. If no demonstrable benefit after [adequate trial period], discontinue and reassess.

CONTROLLED SUBSTANCE MONITORING ADDENDUM DEA Schedule: [II / III / IV / V] State PDMP Requirements: [Mandatory check required / Recommended per state law] PDMP REVIEW: Reviewed on: [MM/DD/YYYY] Result: [Consistent with prescribed regimen — no unexpected controlled substances identified.] OR [Unexpected findings: specify prescribers, medications, dates — clinical response documented below.] Clinical response to unexpected findings: [action taken] UDS: Date: [MM/DD/YYYY] / [Not collected this visit — rationale: ___] Results: [Expected substances present / Unexpected substance: specify / Expected substance absent: document discussion] Clinical response to unexpected UDS result: [action taken] CONTROLLED SUBSTANCE AGREEMENT: Status: [Signed [date] — copy in chart / Reviewed verbally today / Updated [date]] Patient reminded: prescription is for personal use only; sharing/selling is illegal. PRESCRIPTION DETAILS: Quantity dispensed: [___] [tablets/capsules/films] Days supply: [___] Refills authorized: [0 — Schedule II / __ — Schedule III-V] No early refills: patient notified. Next prescription date: [___] Lost/stolen prescriptions: patient instructed to report to office and pharmacy. NEXT MONITORING: PDMP: at next visit / [date] UDS: random / [date] CS agreement review: [date]