OTC (10-20 mg) and [[USLegal:Prescription only|Rx-only]] (higher doses) in US OTC (20 mg) and [[USLegal:Prescription only|Rx-only]] (higher doses) in US OTC (20 mg, 14-day course) and [[USLegal:Prescription only|Rx-only]] (higher and longer durations) in US OTC (Astepro 0.15%) and [[USLegal:Prescription only|Rx-only]] (other intranasal, ophthalmic, Dymista) in US OTC (MiraLAX) and [[USLegal:Prescription only|Rx-only]] (electrolyte solutions for bowel prep) in US OTC (Nasonex 24HR) and [[USLegal:Prescription only|Rx-only]] (other forms) in US OTC (Pataday ophthalmic) and [[USLegal:Prescription only|Rx-only]] (Patanase intranasal) in US OTC (intranasal Flonase) and [[USLegal:Prescription only|Rx-only]] (inhaled, topical) in US OTC (intranasal Rhinocort Allergy) and [[USLegal:Prescription only|Rx-only]] (other forms) in US OTC (low-dose topicals) and [[USLegal:Prescription only|Rx-only]] (other forms) in US OTC (low-dose) and [[USLegal:Prescription only|Rx-only]] (1 mg, injectable) in US OTC (low-dose) and [[USLegal:Prescription only|Rx-only]] (50,000 IU and concentrated solutions) in US OTC (low-dose, dietary supplement) and [[USLegal:Prescription only|Rx-only]] (Niaspan ER) in US OTC (low/mid-dose oral) and [[USLegal:Prescription only|Rx-only]] (injection, intranasal) in US OTC (lower doses) and [[USLegal:Prescription only|Rx-only]] (higher doses) in US OTC (lower strengths) and [[USLegal:Prescription only|Rx-only]] (combination with betamethasone) in US OTC (lower-concentration washes) and [[USLegal:Prescription only|Rx-only]] (Peridex oral rinse, ChloraPrep) in US OTC (lowest-strength topicals) and [[USLegal:Prescription only|Rx-only]] (higher strengths, injectable) in US OTC (most dentifrice and rinse) and [[USLegal:Prescription only|Rx-only]] (high-concentration paste/gel, supplements) in US OTC (most) and [[USLegal:Prescription only|Rx-only]] (50,000 IU) in US OTC (ophthalmic ointment) and [[USLegal:Prescription only|Rx-only]] (other forms) in US OTC (oral salts) and [[USLegal:Prescription only|Rx-only]] (IV) in US OTC (oral supplements) and [[USLegal:Prescription only|Rx-only]] (IV) in US OTC (topical) and [[USLegal:Prescription only|Rx-only]] (oral) in US OTC (transdermal patch in women) and [[USLegal:Prescription only|Rx-only]] (other forms) in US OTC and [[USLegal:Prescription only|Rx-only]] (IV, combination products) in US Plant unrestricted; pharmaceutical atropine Rx-only Rx, '''not a controlled substance''' (no DEA scheduling) Rx, '''not a controlled substance''' (unique among wake-promoting agents) Rx, Schedule III (US). REMS program required. Rx-only in US (REMS program) Rx-only;'"`UNIQ--ref-0000005C-QINU`"' not a controlled substance Rx-only;'"`UNIQ--ref-000000F0-QINU`"' not a controlled substance Rx-only;'"`UNIQ--ref-0000018D-QINU`"' not a controlled substance Rx-only;'"`UNIQ--ref-00000256-QINU`"' not a controlled substance Rx-only;'"`UNIQ--ref-00000305-QINU`"' not a controlled substance Rx. FDA black-box warning for increased mortality in elderly patients with dementia-related psychosis (class warning shared with all antipsychotics) Rx; ARIA monitoring required Rx; REMS program required (excessive sedation/loss of consciousness during infusion) Rx; REMS-like program for ARIA monitoring Rx; black-box warning for distant spread of toxin effect Schedule I (United States) Schedule I in US since 1993 (despite traditional use elsewhere); legal in Ethiopia, Kenya, Yemen, Somalia, Djibouti Schedule III (DEA, US) Schedule III in US; X-waiver no longer required (as of 2023) Schedule III; REMS-restricted (Schedule I if outside the pharmaceutical channel, same molecule as illicit GHB) Schedule IV (US) US Schedule II (single-entity); Schedule III–V (combination products by content). Unrestricted (food) Withdrawn from US market January 2024 [[USLegal:DEA Schedule II|Schedule II]] controlled substance in US (rescheduled from Schedule III in 1978). No accepted medical use. UN Convention on Psychotropic Substances Schedule II internationally.'"`UNIQ--ref-00000067-QINU`"' [[USLegal:Over-the-counter|OTC]] as Bonine and Dramamine Less Drowsy; [[USLegal:Prescription only|Rx-only]] as Antivert [[USLegal:Over-the-counter|OTC]] dietary supplement in the US ('''not FDA-regulated as a medicine'''; multiple studies show OTC products contain 50-470% of labeled melatonin content); [[USLegal:Prescription only|Rx-only]] in the EU and UK [[USLegal:Over-the-counter|OTC]] for most oral and topical formulations; [[USLegal:Prescription only|Rx-only]] for injectable [[USLegal:Over-the-counter|OTC]] in US at all standard strengths [[USLegal:Over-the-counter|OTC]] in US at ≤220 mg/tablet and ≤660 mg/day; [[USLegal:Prescription only|Rx-only]] at higher strengths [[USLegal:Over-the-counter|OTC]] in the US at ≤200 mg per tablet / ≤1200 mg/day; [[USLegal:Prescription only|Rx-only]] at higher strengths and indications [[USLegal:Prescription only|Prescription only]]; not a controlled substance [[USLegal:Prescription only|Rx-only]] (higher concentrations and IV) and OTC (low-dose supplements) in US [[USLegal:Prescription only|Rx-only]] for IV formulations; OTC for oral [[USLegal:Prescription only|Rx-only]] for most formulations; some low-concentration topical formulations are [[USLegal:Over-the-counter|OTC]] (4% cream) [[USLegal:Prescription only|Rx-only]] for oral and most topical formulations in US; Voltaren Arthritis Pain 1% gel switched to [[USLegal:Over-the-counter|OTC]] in 2020 [[USLegal:Prescription only|Rx-only]] for parenteral formulations; OTC for oral, nasal, and many nebulizer products [[USLegal:Prescription only|Rx-only]] in US (most products; some low-volume packs OTC) [[USLegal:Prescription only|Rx-only]] in US (note: norgestrel 0.075 mg POP is now OTC as Opill since 2023, but norethindrone POP remains Rx) [[USLegal:Prescription only|Rx-only]] in US (some OTC formulations exist) [[USLegal:Prescription only|Rx-only]] in US (the veterinary preparations are not for human use) [[USLegal:Prescription only|Rx-only]] in US since 2020 (OTC 2% formulations withdrawn under CARES Act due to safety concerns) [[USLegal:Prescription only|Rx-only]] in US. '''Contraindicated in structural heart disease''' — CAST trial (1989) showed increased mortality from class IC agents in patients with prior MI; modern use is limited to structurally normal hearts'"`UNIQ--ref-00001141-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. '''FDA Boxed Warning (2020):''' neuropsychiatric events including agitation, depression, sleep disturbance, and suicidal thoughts; benefit-risk should be reassessed regularly'"`UNIQ--ref-00000160-QINU`"'. [[USLegal:Prescription only|Rx-only]] in US. '''Federally non-controlled despite being a barbiturate''', a paradoxical situation given that its primary active metabolite phenobarbital is Schedule IV'"`UNIQ--ref-00000019-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. '''Not a controlled substance''', the principal clinical selling point versus psychostimulant ADHD options. Carries the antidepressant-class '''Boxed Warning''' for suicidal ideation in pediatric patients'"`UNIQ--ref-00000016-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries '''Boxed Warning''' for risk of malignancy and serious infection; nephrotoxicity, hypertension, and immunosuppression-associated complications'"`UNIQ--ref-00000A93-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries '''Boxed Warnings''' for hepatotoxicity (especially children <2 with metabolic disorders), teratogenicity, and pancreatitis'"`UNIQ--ref-0000097F-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries '''Boxed Warnings''' for pulmonary toxicity (interstitial pneumonitis, fibrosis), hepatotoxicity, and proarrhythmia'"`UNIQ--ref-00000CB5-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries a '''Boxed Warning''' contraindicating use in children <2 years (lethal dehydration in animal studies)'"`UNIQ--ref-0000119E-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries a '''Boxed Warning''' for '''tardive dyskinesia''' (irreversible movement disorder), driving the 12-week chronic-use limit'"`UNIQ--ref-00000EFB-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries a '''Boxed Warning''' for Clostridioides difficile colitis (one of the most C. difficile-inducing antibiotic classes)'"`UNIQ--ref-00001444-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries a '''Boxed Warning''' for bleeding risk and against aspirin maintenance doses above 100 mg/d (reduces ticagrelor efficacy, per PLATO subgroup analysis)'"`UNIQ--ref-00000C94-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries a '''Boxed Warning''' for bone mineral density loss with prolonged use (≥2 years; partially reversible after discontinuation)'"`UNIQ--ref-00000F22-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries a '''Boxed Warning''' for heart failure (do not initiate in NYHA III/IV; can precipitate or worsen HF in any patient)'"`UNIQ--ref-00000826-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries the '''antidepressant Boxed Warning''' for suicidality in children/adolescents/young adults and the atypical-neuroleptic '''Boxed Warning''' for increased mortality in elderly dementia patients'"`UNIQ--ref-0000154F-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries the FDA '''Boxed Warning for serious skin reactions''' including Stevens-Johnson syndrome and toxic epidermal necrolysis, with the risk concentrated in the first 2-8 weeks of therapy and elevated by rapid titration'"`UNIQ--ref-00000028-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries the NSAID-class '''Boxed Warning''' for cardiovascular thrombotic events and serious GI bleeding'"`UNIQ--ref-000011FB-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries the antidepressant '''Boxed Warning''' for suicidality in children, adolescents, and young adults. Not controlled'"`UNIQ--ref-00000025-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries the antidepressant '''Boxed Warning''' for suicidality in children, adolescents, and young adults'"`UNIQ--ref-0000001C-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries the antidepressant '''Boxed Warning''' for suicidality in children, adolescents, and young adults'"`UNIQ--ref-0000001F-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries the antidepressant '''Boxed Warning''' for suicidality in children, adolescents, and young adults'"`UNIQ--ref-0000002E-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries the atypical-neuroleptic '''Boxed Warning''' for increased mortality in elderly patients with dementia-related psychosis'"`UNIQ--ref-00000023-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries the same fluoroquinolone-class '''Boxed Warnings''' as ciprofloxacin/levofloxacin'"`UNIQ--ref-00000D84-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries the same fluoroquinolone-class '''Boxed Warnings''' as ciprofloxacin/levofloxacin'"`UNIQ--ref-000014C5-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Carries the same fluoroquinolone-class '''Boxed Warnings''' as ciprofloxacin: tendinitis/tendon rupture (especially elderly, corticosteroid co-use), peripheral neuropathy, CNS effects, worsening of myasthenia gravis'"`UNIQ--ref-00000CF7-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Caution with QT-prolonging medicines (quinidine itself is class IA antiarrhythmic, and the dose here, though sub-antiarrhythmic, still contributes to QT)'"`UNIQ--ref-00001585-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. NSAID-class '''Boxed Warning''' for CV thrombotic events and GI bleeding; triptans contraindicated in coronary artery disease, peripheral vascular disease, uncontrolled hypertension, and recent ergot or MAOI use'"`UNIQ--ref-000015D3-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. NSAID-class '''Boxed Warning''' for CV thrombotic events and GI bleeding'"`UNIQ--ref-00001270-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Not a controlled substance, distinguishing it from carisoprodol among muscle-spasm options'"`UNIQ--ref-0000001F-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Not a controlled substance, distinguishing it from carisoprodol which is Schedule IV'"`UNIQ--ref-00000019-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Not a controlled substance, distinguishing it from the carisoprodol alternative for muscle spasm'"`UNIQ--ref-0000001C-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Not a controlled substance, like guanfacine and unlike the psychostimulant alternatives for ADHD'"`UNIQ--ref-00000028-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Not a controlled substance, which is a meaningful clinical advantage over benzodiazepine alternatives for chronic anxiety'"`UNIQ--ref-0000001F-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Not a controlled substance, which is a meaningful clinical advantage over the benzodiazepine alternatives for short-term anxiety'"`UNIQ--ref-00000028-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Not a controlled substance, which is a meaningful contrast to the psychostimulant alternatives for ADHD'"`UNIQ--ref-00000022-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Not a controlled substance'"`UNIQ--ref-00000022-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Not a controlled substance'"`UNIQ--ref-00000028-QINU`"' [[USLegal:Prescription only|Rx-only]] in US. Not a controlled substance'"`UNIQ--ref-0000002B-QINU`"' [[USLegal:Schedule III|Schedule III controlled substance]] in US (Fiorinal is scheduled federally; Fioricet with acetaminophen is unscheduled federally despite identical butalbital content, a regulatory quirk) [[USLegal:Schedule III|Schedule III controlled substance]] in US. '''Contraindicated in children <12''' for any indication and in any age post-tonsillectomy/adenoidectomy (FDA 2017 black-box advisory)'"`UNIQ--ref-00001519-QINU`"' [[USLegal:Schedule II|Schedule II controlled substance]] in US [[USLegal:Schedule II|Schedule II controlled substance]] in US. Acetaminophen content limited to ≤325 mg per dosage unit (FDA 2014) [[USLegal:Schedule II|Schedule II controlled substance]] in US; WHO essential medicine'"`UNIQ--ref-00000022-QINU`"' [[USLegal:Schedule II|Schedule II controlled substance]] in US'"`UNIQ--ref-00000019-QINU`"' [[USLegal:Schedule II|Schedule II controlled substance]] in US'"`UNIQ--ref-0000001F-QINU`"' [[USLegal:Schedule IV|Schedule IV controlled substance]] in US (federally scheduled 2014); some states schedule higher'"`UNIQ--ref-0000001F-QINU`"' [[USLegal:Schedule IV|Schedule IV controlled substance]] in US (tramadol was reclassified from non-controlled to Schedule IV in 2014 after recognition of dependence risk) [[USLegal:Schedule IV|Schedule IV controlled substance]] in US. Carries the FDA '''Boxed Warning''' for '''complex sleep behaviors''' (sleep-driving, sleep-walking, sleep-eating, other parasomnias) added in 2019'"`UNIQ--ref-0000001C-QINU`"' [[USLegal:Schedule IV|Schedule IV controlled substance]] in US. Carries the benzodiazepine class '''Boxed Warning''' for risk of fatal respiratory depression, coma, and death when combined with opioids'"`UNIQ--ref-00000025-QINU`"'