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Medicines > pregnancy : Category C or Limited data; avoid

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generic:
None (10) · Bisoprolol (1) · Dexmethylphenidate (1) · Duloxetine (1) · Haloperidol (1) · Metoprolol (1) · Mixed amphetamine salts (1) · Nebivolol (1) · Prazosin (1) · Propranolol (1) · Sodium Oxybate (1)
brand:
Adderall, Adderall XR, Mydayis (1) · Aimovig (1) · Ajovy (1) · Auvelity (dextromethorphan/bupropion ER) (1) · Belsomra (1) · Bystolic (1) · Cymbalta, Drizalma Sprinkle, Irenka, Yentreve (1) · Dayvigo (1) · Emgality (1) · Focalin, Focalin XR (1) · Haldol, Serenace, Haldol Decanoate (1) · Inderal (1) · Lopressor (tartrate), Toprol XL (succinate) (1) · Minipress (1) · Nuplazid (1) · Quviviq (1) · Vyepti (1) · Xyrem; Xywav (lower-sodium formulation with Ca/Mg/K salts) (1) · Zavzpret (zavegepant) (1) · Zebeta (1)
classes:
Alpha-1 Adrenergic Antagonist (1) · Amphetamine (1) · Anti-CGRP ligand monoclonal antibody (3) · Anti-CGRP receptor monoclonal antibody (1) · Antidepressant (1) · Antiemetic (1) · Anxiolytic (1) · Beta Blocker (4) · Cardioselective (β1) (2) · Cardioselective (β1) + vasodilator (1) · CGRP receptor antagonist (1) · CNS stimulant (1) · Dual orexin receptor antagonist (DORA) (3) · GABAB Agonist; Endogenous GHB receptor agonist (1) · Gepant (1) · NDRI (1) · NMDA receptor antagonist + sigma-1 agonist + NDRI (combination) (1) · Non-selective (1) · Psychostimulant (2) · Selective 5HT2A inverse agonist (with weaker 5HT2C inverse agonism) (1) · SNRI (1) · the first approved (1) · Typical antipsychotic (1)
mechanism:
None (2) · Agonist at the metabotropic GABAB receptor and the endogenous γ-hydroxybutyrate (GHB) receptor. Produces deep sleep with increased slow-wave architecture, suppression of REM intrusion, and cataplexy reduction. (1) · Cardioselective β1-adrenergic antagonist. Selectivity is dose-dependent and partially lost at higher doses. (1) · Competitive antagonist at OX1R and OX2R. Faster receptor association/dissociation kinetics than suvorexant (~16 sec dissociation vs ~57 sec) hypothesized to support sleep onset, with sufficient duration for maintenance. (1) · Competitive antagonist at OX1R and OX2R. First-in-class DORA. Receptor dissociation slower than lemborexant or daridorexant. (1) · High-affinity D2 receptor antagonist (1) · Highly β1-selective adrenergic antagonist. Greater selectivity than metoprolol or atenolol. (1) · Humanized IgG1 monoclonal antibody binding CGRP peptide; IV infusion enables fastest onset of any CGRP mAb (1) · Humanized IgG2 monoclonal antibody binding both isoforms of CGRP peptide (1) · Humanized IgG2 monoclonal antibody binding the CGRP receptor (not the peptide); blocks CGRP-mediated vasodilation and nociceptive signaling (1) · Humanized IgG4 monoclonal antibody binding CGRP peptide; prevents CGRP from activating its receptor (1) · Non-selective competitive antagonist at β1 and β2 adrenergic receptors. Lipophilic; significant blood–brain barrier penetration, accounting for its CNS effects. (1) · Norepinephrine–dopamine reuptake inhibition (DAT, NET), d-threo enantiomer of methylphenidate (1) · Selective alpha-1 adrenergic receptor antagonist. Lowers peripheral vascular resistance via vasodilation; in the CNS, blunts noradrenergic hyperarousal thought to drive trauma-related nightmares. (1) · Selective inverse agonist at 5HT2A receptors with weaker activity at 5HT2C. Has no significant dopamine D2 affinity, unique among approved antipsychotics. Inverse agonism (rather than antagonism) reduces constitutive 5HT2A receptor activity below baseline. (1) · Serotonin–norepinephrine reuptake inhibition (balanced) (1) · Small-molecule CGRP receptor antagonist; intranasal formulation (1) · TAAR1 agonism, VMAT2 substrate, DAT/NET reverse transport, net release of dopamine and norepinephrine (1) · The d-enantiomer is a highly β1-selective antagonist; the l-enantiomer triggers endothelial nitric-oxide–mediated vasodilation. Unique among beta blockers for this NO mechanism. (1)
uses:
Acute treatment of migraine with or without aura in adults (1) · Depression, anxiety, neuropathic pain, fibromyalgia, chronic musculoskeletal pain (1) · Hallucinations and delusions associated with Parkinson's disease psychosis (PDP). Investigational for psychosis in other dementias and as augmentation for depression. (1) · Insomnia (sleep onset and/or maintenance) in adults (FDA-approved August 2014). Also studied for insomnia in mild-moderate Alzheimer disease. (1) · Insomnia (sleep onset and/or maintenance) in adults (FDA-approved Dec 2019) (1) · Insomnia (sleep onset and/or sleep maintenance) in adults (FDA-approved Jan 2022) (1) · Major depressive disorder in adults (FDA-approved August 2022) (1) · Preventive treatment of migraine in adults (1) · Preventive treatment of migraine in adults (episodic and chronic) (2) · Preventive treatment of migraine in adults; episodic cluster headache (1) · Schizophrenia, acute psychosis, agitation, delirium, Tourette syndrome, severe nausea (1) · '"`UNIQ--vote-00000150-QINU`"', '"`UNIQ--vote-00000151-QINU`"' (1) · '"`UNIQ--vote-000004F5-QINU`"', '"`UNIQ--vote-000004F6-QINU`"', '"`UNIQ--vote-000004F7-QINU`"', '"`UNIQ--vote-000004F8-QINU`"', '"`UNIQ--vote-000004F9-QINU`"' (1) · '"`UNIQ--vote-00000562-QINU`"', '"`UNIQ--vote-00000563-QINU`"', '"`UNIQ--vote-00000564-QINU`"', '"`UNIQ--vote-00000565-QINU`"', '"`UNIQ--vote-00000566-QINU`"' (1) · '"`UNIQ--vote-0000059D-QINU`"' (1) · '"`UNIQ--vote-000005D0-QINU`"', '"`UNIQ--vote-000005D1-QINU`"', '"`UNIQ--vote-000005D2-QINU`"' (1) · '"`UNIQ--vote-000005E7-QINU`"', '"`UNIQ--vote-000005E8-QINU`"', '"`UNIQ--vote-000005E9-QINU`"', '"`UNIQ--vote-000005EA-QINU`"', '"`UNIQ--vote-000005EB-QINU`"' (1) · '"`UNIQ--vote-00000636-QINU`"', '"`UNIQ--vote-00000637-QINU`"', '"`UNIQ--vote-00000638-QINU`"' (1) · '"`UNIQ--vote-00000717-QINU`"', '"`UNIQ--vote-00000718-QINU`"', '"`UNIQ--vote-00000719-QINU`"' (1)
starting dose:
None (3) · 1 mg at bedtime (PTSD nightmares); 1 mg BID–TID (HTN) (1) · 1 tablet (dextromethorphan 45 mg / bupropion 105 mg) PO daily × 3 days, then increase to 1 tablet BID (1) · 10 mg (one spray) intranasally in one nostril (1) · 10 mg PO 30 min before bedtime (with ≥7 hours of sleep planned) (1) · 100 mg IV every 3 months; may increase to 300 mg IV every 3 months (1) · 10–40 mg (situational anxiety); 40 mg BID (HTN) (1) · 2.25 g at bedtime + 2.25 g 2.5–4 h later; titrate weekly to 6–9 g/night total (1) · 2.5 mg IR, 5 mg XR, or 12.5mg Mydayis (1) · 2.5–5 mg daily (HTN); 1.25 mg daily (HFrEF, slow titration) (1) · 225 mg SC monthly, or 675 mg SC every 3 months (quarterly) (1) · 25 mg PO at bedtime (no titration); may increase to 50 mg if 25 mg inadequate (1) · 25–50 mg BID (tartrate); 25–100 mg daily (succinate); 12.5 mg daily in HFrEF (1) · 34 mg PO once daily (1) · 5 mg daily (1) · 5 mg PO at bedtime; may increase to 10 mg if inadequate (1) · 70 mg SC monthly; may increase to 140 mg monthly (1) · Migraine: 240 mg SC loading dose, then 120 mg SC monthly. Cluster: 300 mg SC at onset of cluster period, then monthly during cluster. (1)
preparations:
None (3) · 0.5 g/mL oral solution (1) · 1, 2, 5 mg caps (1) · 10 mg, 34 mg capsules/tablets (1) · 10 mg/spray nasal solution (1) · 10, 20, 40, 60, 80 mg tabs; 60/80/120/160 mg ER caps; 1 mg/mL IV (1) · 100 mg/mL vial for IV infusion (1) · 120 mg/mL prefilled syringe or autoinjector (1) · 2.5, 5, 10, 20 mg tabs (1) · 225 mg/1.5 mL prefilled syringe or autoinjector (1) · 25 mg, 50 mg tablets (1) · 5 mg, 10 mg tablets (1) · 5 mg, 10 mg, 15 mg, 20 mg tablets (1) · 5, 10 mg tabs (1) · 70 mg/mL or 140 mg/mL prefilled autoinjector (1) · Dextromethorphan 45 mg + bupropion 105 mg ER tablets (1) · IR tabs 5, 7.5, 10, 12.5, 15, 20, 30 mg; XR caps 5, 10, 15, 20, 25, 30 mg; Mydayis caps 12.5, 25, 37.5, 50 mg (1) · Tartrate: 25, 50, 100 mg tabs; 1 mg/mL IV. Succinate ER: 25, 50, 100, 200 mg. (1)
fda max:
None (3) · 10 mg per 24 h (1) · 10 mg/d (1) · 140 mg/month (1) · 2 tablets/day (dextromethorphan 90 mg / bupropion 210 mg) (1) · 20 mg/d (2) · 240 mg loading + 120 mg/month for migraine; 300 mg/month for cluster (1) · 300 mg/quarter (1) · 34 mg/d (1) · 40 mg/d (2) · 400 mg/d (1) · 50 mg/d (1) · 640 mg/d (HTN); 240 mg/d (migraine) (1) · 675 mg/quarter (1) · 9 g/night (1) · XR = 40 or 60 mg/d; IR = 40 or 60 mg/d'"`UNIQ--ref-00000567-QINU`"' (1)
routes:
IM (1) · Intranasal (1) · Intravenous infusion (1) · IV (3) · Oral (14) · Oral (must be taken in bed; effects within minutes) (1) · Subcutaneous (3)
onset:
15–30 min (fasting) (1) · 1–2 h (2) · 1–2 h (PO), immediate (IV) (1) · 1–2 h (PO); immediate (IV) (1) · 30–60 min (1) · 30–90 min (1) · Benefit over weeks of dosing (1) · Effect demonstrated within 24 hours in some patients (1) · IR: 30–60 min; XR: 1–2 h to peak effect (1) · Mood: 2–4 weeks. Pain: often within 1–2 weeks. (1) · Onset of preventive effect over weeks; some patients respond after first dose (1) · Over weeks (2) · Pain relief reported within 15 min in trials (1) · PO 1–2 h; IM 30–60 min; IV 5–20 min (1) · Significant antidepressant response by week 1 in trials (faster than monoaminergic antidepressants which take 4-6 weeks) (1) · ~30 min (3)
duration:
12–24 h (oral); decanoate IM 3–4 weeks (1) · 24 h (2) · 3-month dosing interval (1) · 6–12 h (IR); 24 h (ER) (1) · 6–12 h (tartrate); 24 h (succinate) (1) · 6–8 h (1) · Chronic daily dosing (1) · Daily dosing (1) · IR 4–6 h; XR 10–12 h; Mydayis 14–16 h (1) · IR 4–6 h; XR 8–12 h (1) · Monthly dosing (2) · Monthly or quarterly dosing (1) · Sustained with twice-daily dosing (1) · ~3 h per dose (twice-nightly schedule required) (1) · ~48 h sustained pain freedom in responders (1) · ~7-8 hours (3)
halflife:
14–26 h (oral); ~3 weeks (decanoate) (1) · 2.2 h (IR parent); ~3 h (XR parent) (1) · 2–3 h (1) · 30–60 min (1) · 3–6 h (1) · 3–7 h (1) · 9–12 h (1) · D-amphetamine ~10 h; L-amphetamine ~13 h (adults) (1) · Dextromethorphan ~22 h (when CYP2D6 inhibited); bupropion ~21 h (1) · ~10 h (CYP2D6 extensive metabolizers); up to 31 h (poor metabolizers) (1) · ~12 hours (2) · ~17-19 hours (longer than daridorexant) (1) · ~27 days (2) · ~28 days (1) · ~31 days (1) · ~57 hours (parent), ~200 h (active metabolite) (1) · ~6.6 h (1) · ~8 hours (shorter than suvorexant and lemborexant) (1)
bioavailability:
100% (IV) (1) · Not characterized; oral dosing once daily (1) · Not formally characterized for the combination (1) · Not formally established (1) · Not formally established (high SC) (1) · ~12% (extensive metabolizers); ~96% (poor metabolizers) (1) · ~22–25% (1) · ~25% (extensive hepatic first-pass) (1) · ~25% (high first-pass) (1) · ~44% (1) · ~5% intranasal (1) · ~50% (1) · ~50% (highly variable) (1) · ~60% (1) · ~60–70% (oral) (1) · ~62% (1) · ~75–90% (oral) (1) · ~82% (1) · ~82% SC (1) · ~90% (low first-pass) (1)
pregnancy: (Click arrow to add another value)
legal:
Rx (6) · Rx, Schedule IV (US) (3) · Rx-only (2) · Rx-only in US (5) · Rx. FDA black-box warning for increased mortality in elderly patients with dementia-related psychosis (class warning shared with all antipsychotics) (1) · Schedule II (2) · Schedule III; REMS-restricted (Schedule I if outside the pharmaceutical channel, same molecule as illicit GHB) (1)

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