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Choose a table:
Medicines (732)
Medicines
> fda max:
400 mg/day.'"`UNIQ--ref-0000006C-QINU`"'
&
legal:
None
Use the filters below to narrow your results.
generic:
Modafinil (1)
brand:
Provigil (Teva/Cephalon); Alertec (Canada); Modavigil (Australia) (1)
classes:
[[:Category:Eugeroics|Eugeroic]] (1)
·
[[:Category:Psychostimulants|Psychostimulant]] (atypical) (1)
mechanism:
None
(1)
uses:
None
(1)
starting dose:
None
(1)
preparations:
Tablets: 100 mg, 200 mg (scored). [[Armodafinil]] (Nuvigil), the R-enantiomer of modafinil, is available separately as 50 mg, 150 mg, 200 mg, and 250 mg tablets. (1)
fda max:
(Click arrow to add another value)
None
·
Indication-specific
·
40 mg/d
·
10 mg/d
·
20 mg/d
·
80 mg/d
·
10 mg/d (adults)
·
100 mg/d
·
4 g/d
·
400 mg/d
·
40 mg/d typical; up to 240 mg/d for Zollinger-Ellison
·
5 mg/d
·
50 mg/d
·
600 mg/d
·
No fixed ceiling; titrate to clinical effect and tolerability with CDC opioid prescribing guidance constraints on morphine-milligram-equivalent (MME) totals
·
No fixed maximum; titrated to TSH target
·
TID per eye
·
Titrated to glucose; no fixed ceiling
·
Titrated to glucose; no fixed maximum
·
'''20 mg/day in adults >60 years''' per FDA's 2011-2012 QT-prolongation warning; 40 mg/day in adults ≤60
Other values:
'''4.5 mg/kg (without epinephrine), 7 mg/kg (with epinephrine)''' for infiltration; serum level monitoring required for prolonged IV antiarrhythmic use
0.5 mg/d
0.8 mg/d (rarely needed)
1 capsule BID (40 mg DXM / 20 mg quinidine per day)
1 drop per eye q8-12h
1 drop/eye/day (more frequent dosing reduces efficacy)
1 g/d (oral); 6 g/d (IV)
1 mg/d
1 mg/d typical Rx; higher in specific indications
1.8 mg in any 1-hour period (acute gout); 1.2 mg/d (prophylaxis with renal/hepatic impairment); much lower with strong CYP3A4 or P-gp inhibitors
1.8 mg/day SC (Victoza, T2DM)'"`UNIQ--ref-00000185-QINU`"' · 3.0 mg/day SC (Saxenda, obesity)'"`UNIQ--ref-00000186-QINU`"'
10 mg BID for the first 7 days of acute VTE; otherwise 5 mg BID
10 mg per 24 h
10 mg/d (5 mg if severe renal or moderate hepatic impairment, or strong CYP3A4 inhibitors)
10 mg/day (IR); 12.5 mg/day (CR)
10 mg/day (anxiety, oral)
10 mg/kg q2w
10 µg twice daily (Byetta)'"`UNIQ--ref-000000E7-QINU`"' · 2 mg once weekly (Bydureon BCise)'"`UNIQ--ref-000000E8-QINU`"'
100 mcg/d typical
100 mg/d (ED); 20 mg TID (PAH)
100 mg/d (rarely used)
100 mg/day (adult)
100 mg/day (adult); 1.4 mg/kg/day or 100 mg total (pediatric, whichever lower)
100 mg/day (vertigo)
100-200 mg/day depending on indication
1000 mg/d (osteoarthritis); 1200 mg/d (rheumatoid arthritis)
12 inhalations/d (rescue); higher for severe exacerbation under monitoring
12 puffs MDI/d typical; nebulized 2000 mcg/d
120 mg/d (ER); IR not for chronic hypertension
120 mg/day (IV/IM); 40 mg/day (oral); '''5-day maximum total combined therapy''' to mitigate the GI bleeding, AKI, and platelet dysfunction risks
1200 mg/day (adult seizures); 1600 mg/day (bipolar mania)
140 mg/month
1400 mg q4w
15 mg/day (oral); 30 mg IV once daily (Anjeso)
15 mg/wk SC'"`UNIQ--ref-000002FE-QINU`"''"`UNIQ--ref-000002FF-QINU`"'
150 mg/d
150 mg/d (treatment)
150 mg/day (oral); use lowest effective dose for shortest duration per FDA NSAID class guidance
150 mg/day; therapeutic plasma-level monitoring recommended (target 50-150 ng/mL window)
1500 mg/day (Rx); 660 mg/24h (OTC, without provider direction)
16 mg/d (8 mg/d OTC)
16 mg/d (IR); 8 mg/d (XL)
16 mg/day (schizophrenia, adult); 6 mg/day (bipolar maintenance, autism irritability)
160 mg/d (Zollinger-Ellison); 80 mg/d for routine indications
160 mg/d (rarely tolerated due to anticholinergic effects)
1600 mg/day (theoretical seizure dosing); practical use 400 mg/day for seizures, 100-200 mg/day for migraine prophylaxis
18 mg olanzapine / 75 mg fluoxetine per day
180 mg/d (adults)
195 units/treatment for chronic migraine; max varies by problem
2 g/d (Niaspan); higher off-label use historical
2 g/d typical
2 g/day (seizures); typically much lower for essential tremor
2 mg/wk SC (Ozempic)'"`UNIQ--ref-0000024B-QINU`"' · 2.4 mg/wk SC (Wegovy)'"`UNIQ--ref-0000024C-QINU`"' · 14 mg PO daily (Rybelsus)'"`UNIQ--ref-0000024D-QINU`"'
2 sprays/nostril BID
2 tablets per 24 hours; ≤4 days per month to avoid medicine-overuse headache
2 tablets/day (dextromethorphan 90 mg / bupropion 210 mg)
2.4 g/d
2.4 mg/day (HTN, IR); 0.4 mg/day (ADHD, Kapvay)
20 mg/d (ED, PRN); 5 mg/d (daily / BPH); 40 mg/d (PAH)
20 mg/d (hypertension); 10 mg/d (other indications typical)
20 mg/day (IR); 28 mg/day (XR)
20 mg/day (adult); 10 mg/day in elderly and in hepatic impairment
20 mg/day (oral)
20 mg/day (seizures); commonly limited to 4 mg/day for anxiety in current practice
200 mg/d
200 mg/d (100 mg/d if on CYP3A4 inhibitors)
200 mg/d typical practical ceiling
200 mg/day (oral); 12 mg/day (SC); 40 mg/day (nasal spray); 44 mg/day (Onzetra)
200 mg/day (typical adult oral)
2000 mg/d
225 mg/day outpatient (XR); 375 mg/day inpatient (IR divided TID); 75 mg/day in moderate hepatic impairment
23 mg/day
24 mg/day (Parkinson disease); 4 mg/day (restless legs syndrome)
24/6 mg/d (most labels)
240 mg loading + 120 mg/month for migraine; 300 mg/month for cluster
240 mg/d (mononitrate ER); 160 mg/d (dinitrate)
240 mg/day
2400 mg/day (adult)
2400 mg/day (oral); 300 mg total per IV bolus dosing series
25 mg/d
25 mg/day (ADHD per Desoxyn label); 15 mg/day (obesity, short-term, per Desoxyn label)
250 mg/d
2550 mg/d (IR); 2000 mg/d (ER)
28/10 mg/d
290 mcg/d
3 g/d (zoster)
3 g/d typical; higher in severe infections under specialist guidance
30 mg/24 hours
30 mg/d (XL) typical
30 mg/d (acute VTE first 21 days as 15 mg BID); otherwise 20 mg/d
30 mg/d for short-term use
30 mg/day (IR or ER)
30 mg/day (adult schizophrenia); 15 mg/day (MDD adjunct)
300 mg/d
300 mg/d typical practical limit (toxicity rises sharply above)
300 mg/day (IR or CR)
300 mg/day (depression, hospitalized); 150 mg/day outpatient; 6 mg/day for insomnia
300 mg/day (historical hospitalized inpatient depression); 150 mg/day outpatient typical ceiling
300 mg/day (oral)
300 mg/quarter
3000 mg/day
32 mg naltrexone / 360 mg bupropion per day
32 mg/day adult; weight-based pediatric ceiling
320 mg/d (hypertension); 320 mg/d (HF)
3200 mg/day (Rx); 1200 mg/day (OTC, without provider direction)
34 mg/d
35.6 mg/d
36 mg/day in three divided doses; single dose maximum 16 mg
360 mg/day
3600 mg/day; off-label doses higher are common but bioavailability saturates well below this
37.5 mg/d
4 L per procedure (standard-volume products)
4 g/d (rarely tolerated due to GI effects)
4 g/d in healthy adults; 3 g/d conservative limit; 2 g/d in cirrhosis or chronic alcohol use
4 g/d typical
4 mg/d (schizophrenia); 3 mg/d (AD agitation); 3 mg/d (MDD adjunct)
4% topical; limit duration of use
4.5 mg/day (Parkinson disease); 0.5 mg/day (restless legs syndrome)
4.5 mg/wk SC'"`UNIQ--ref-00000055-QINU`"'
4.8 g/d (IV severe infection)
40 mg every week (selected indications); otherwise 40 mg every other week
40 mg/d (IR; doses >15 mg given as divided BID); 20 mg/d (XL)
40 mg/d (rarely needed; 40 mg restricted to patients not at goal on 20 mg)
40 mg/d standard; 80 mg/d restricted to patients tolerating 80 mg for ≥12 months without myopathy (post-SEARCH 2011 FDA restriction)
40 mg/d typical; up to 360 mg/d for Zollinger-Ellison
40 mg/day (oral, anxiety)
400 mg/d (acute primary aldosteronism diagnosis); 100-200 mg/d typical chronic
400 mg/d (pediatric); 600 mg/d (adult)
400 mg/d (rarely used)
400 mg/d typical maintenance; weight-adjusted ceiling per ophthalmology guidance
400 mg/day (IR, adult); 300 mg/day (ER); 300 mg/day in elderly >75 years
400 mg/day (bipolar monotherapy); 700 mg/day (epilepsy with enzyme-inducing comedication)
400 mg/day for chronic indications; higher for short-term acute pain
400 mg/day outpatient; 600 mg/day inpatient
400 mg/day theoretical; in practice rarely exceeds 200 mg/day
400 mg/day.'"`UNIQ--ref-0000006C-QINU`"'
4000 mg/day (analgesic)
42 mg/d
420 mg/month
45 mg/d
45 mg/day
450 mg/day; doses above this raise seizure risk steeply
5 mg/d (adults)
50 g/week (cream/ointment); 2-week continuous limit; 4-week maximum cumulative
50 mg BID in heart failure (or once-daily equivalent CR); 25 mg BID in hypertension
50 mg/d (hypertension); up to 200 mg/d (edema)
50 mg/d × 14 d
50 mg/day (IR); 62.5 mg/day (CR); 60 mg/day (OCD)
50 mg/day (no efficacy benefit shown for higher doses despite the 100 mg strength being available)
50 mg/day oral; 380 mg/4 weeks IM (Vivitrol); 32 mg + 360 mg naltrexone/bupropion daily (Contrave maximum after titration)
500 mg/d (typical regimen); single 2 g for Zmax; 2 g for select STIs
6 capsules/d (300 mg butalbital, 1950 mg acetaminophen, 240 mg caffeine)
6 capsules/d (300 mg butalbital, 1950 mg aspirin, 240 mg caffeine)
6 mg/d (psychosis/mania); 3 mg/d (depression adjunct)
60 mg/d typical
60 mg/day
60 mg/day (oral, hypertension); 0.5% BID (ophthalmic)
60 mg/kg/d (typically up to 3000 mg/d)
600 mg/d typical practical ceiling in heart failure
600 mg/day (seizures); 450 mg/day (fibromyalgia and neuropathic pain)
640 mg/d (HTN); 240 mg/d (migraine)
675 mg/quarter
7 mg/day in children and adolescents; weight-based ceiling (~0.12 mg/kg/day) applies in smaller patients
70 mg/day
70 mg/week treatment; 40 mg/d for 6 months in Paget's
75 mg per dose; one dose per 24 hours (acute); one dose every other day (preventive)
75 mg/d maintenance (loading doses are single events)
750 mg/d
8 g/day (oral, short-term load); 6 g/day (chronic)
8 mg/d
8 tablets/d (300 mg tramadol / 2600 mg acetaminophen); 5-day duration limit per label
80 mg/d (40 mg/d if combined with diltiazem, verapamil, danazol; lower limits with various interactions)
80 mg/day oral (higher off-label)
800 mg/d
800 mg/d (rarely needed)
800 mg/d (severe invasive disease)
800 mg/day
84 mg per session
9 g/night
90 mg BID (acute year); 60 mg BID (chronic post-MI)
900 mg/day (split into BID or TID dosing). Clinical practice rarely exceeds 600 mg/day; seizure risk increases substantially above 600 mg/day and requires consideration of prophylactic anticonvulsant.'"`UNIQ--ref-0000004A-QINU`"'
Acetaminophen 4 g/d absolute (3 g/d conservative); oxycodone titrated to effect
Acetaminophen 4 g/d absolute; codeine 240-360 mg/d typical practical limit
Aspirin GI/bleeding-limited; oxycodone titrated to effect
BID topical; once daily nail lacquer
Formulation-dependent
Formulation-specific (e.g., 145 mg/d Tricor, 200 mg/d Lipofen)
Formulation-specific; ~4.8 g/d typical maximum oral
ICS 880 mcg/d (asthma); intranasal 200 mcg/d
ICS ~1280 mcg/d; intranasal 256 mcg/d; Entocort 9 mg/d standard
IV peripheral 10 mEq/h (40 mEq/L); IV central 20 mEq/h with cardiac monitoring; PO single doses generally ≤40 mEq
IV: monitored by levels (trough <1 mg/L for extended-interval; <2 mg/L for traditional)
Indication-dependent; 200-400 mg/d oral typical
Indication-specific; ACLS no fixed cumulative ceiling
Indication-specific; HE may require high-volume dosing
Indication-specific; bowel prep regimens reach 4 L cumulative
Indication-specific; high-dose IV regimens for encephalitis or disseminated disease
Indication-specific; lowest effective dose for shortest duration is the WHI-era standard
Indication-specific; renal clearance limits tolerable cumulative dosing
Indication-specific; titrated to effect
Intranasal 200 mcg/d (adults); inhaled 880 mcg/d
Limit to 48 hours of use to avoid hemolysis and methemoglobinemia
Limit topical to 10-day courses to reduce resistance pressure
MOUD: typical effective max 24 mg/day sublingual (doses above offer limited additional mu-occupancy due to ceiling). Pain (Belbuca): 900 mcg every 12 hours.
N/A (never approved)
N/A (no current medical indication)
No defined absolute maximum; dosing is guided by serum level monitoring. Levels above 1.5 mEq/L carry increasing toxicity risk. Levels consistently above 1.2 mEq/L are generally not maintained in clinical practice.'"`UNIQ--ref-00000052-QINU`"'
No fixed maximum; cumulative-dose toxicity drives all chronic decisions
No fixed maximum; titrated to INR target
No fixed maximum; titrated to clinical endpoints
No fixed maximum; titrated to pH and bicarbonate level; chronic high oral doses cause metabolic alkalosis and volume overload
No fixed maximum; titrated; sodium correction rate in chronic hyponatremia must not exceed 8-10 mEq/L per 24 hours to avoid osmotic demyelination
No formal hard ceiling; in MOUD maintenance, doses typically remain at or below 120 mg/day with higher doses reserved for documented under-treatment after careful clinical assessment
No strict ceiling for water-soluble vitamin; UL not set
No strict ceiling; water-soluble vitamin, low toxicity
No strict; Institute of Medicine UL 4,000 IU/d in adults for chronic use
Not FDA-approved; clinical-trial protocols use up to 30 mg in adult investigational dosing
Not formally established (dietary supplement); doses above ~3-5 mg show no additional efficacy but increase next-day sedation risk
Not strictly fixed; long-term Upper Limit ~4,000 IU/d in adults (Institute of Medicine)
Not yet approved
Once daily (Pataday 0.7%); BID (other ophthalmic)
One dose per day
One drop per eye per day
Oral maintenance 400 mg/d typical; higher in refractory cases
Per formulation
Rheumatologic ~25 mg/week; oncology indication-specific
Single 200-400 mcg/kg per dose for systemic indications
Single 60-hour course
Single doses ≤16 mg (FDA 2012 advisory withdrew the 32 mg single IV dose for QT-prolongation risk); 24-32 mg/d divided
Titrated to glucose
Titrated; risk of hypercalcemia is the limiting factor
Topical: BID; troche: 5×/day
Topical: nightly; oral APL: 45 mg/m²/d
Topical: nightly; systemic: regimen-specific
Topical: per formulation; oral supplement age-dependent
Topical: regimen-specific; oral: 400 mg/d in remaining specialty indications
Transplant: regimen-specific
UL 1000 mg (~1500 IU natural)/d in adults; routinely exceeded in older AREDS-1 trials
UL 2000 mg/d in adults
Withdrawn 2024
XR = 40 or 60 mg/d; IR = 40 or 60 mg/d'"`UNIQ--ref-00000567-QINU`"'
~10 mg/d typical
~1500 mg/d (oral); 1200 mg/d (IV)
~200 mg elemental iron/d typical practical limit
~200 mg/d for most indications; higher doses for severe infections
~2500 mg elemental/d combined diet + supplements (chronic; UL)
~4 g/d (severe systemic infection)
~480 mg/d (oral) for cardiovascular indications; higher off-label for cluster
~480 mg/d (oral); IV per protocol
~500 mg/d typical
Search
routes:
Oral (1)
onset:
Peak plasma concentration in 2-4 hours after oral administration. Clinically perceptible wakefulness-promoting effects typically begin within 1-2 hours of dosing.<sup class="pcp-cn" title="This claim needs a citation.">[[[Pharmacopedia:Citation needed|citation needed]]]</sup> (1)
duration:
Effective duration approximately 12-15 hours at the 200 mg dose, consistent with the elimination half-life. A single morning dose generally sustains wakefulness throughout the day without substantially disrupting nighttime sleep onset when taken early.'"`UNIQ--ref-0000006D-QINU`"' (1)
halflife:
None
(1)
bioavailability:
Oral bioavailability is not precisely established in the label but absorption is rapid and essentially complete. Food delays peak plasma concentration by approximately one hour but does not reduce the extent of absorption.'"`UNIQ--ref-0000006F-QINU`"' (1)
pregnancy:
None
(1)
legal:
(Click arrow to add another value)
None
·
[[USLegal:Prescription only|Rx-only]] in US
·
OTC in US
·
Rx
·
Rx-only in US
·
Rx, Schedule IV (US)
·
Schedule II
·
[[USLegal:Prescription only|Rx-only]] in US. Carries the antidepressant '''Boxed Warning''' for suicidality in children, adolescents, and young adults'"`UNIQ--ref-00000028-QINU`"'
·
Rx-only
·
[[USLegal:DEA Schedule I|Schedule I]] (United States)
·
[[USLegal:Prescription only|Rx-only]] in US. Carries the antidepressant '''Boxed Warning''' for suicidality in children, adolescents, and young adults'"`UNIQ--ref-00000022-QINU`"'
·
[[USLegal:Prescription only|Rx-only]] in US. Carries the antidepressant '''Boxed Warning''' for suicidality in children, adolescents, and young adults'"`UNIQ--ref-00000025-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-00000028-QINU`"'
·
'''[[USLegal:Behind-the-counter|Behind-the-counter]] in US''' under the Combat Methamphetamine Epidemic Act 2005: purchase restricted to ≤3.6 g/day and ≤9 g/30 days, with photo ID, logbook signature, and quantity logging required. Several states schedule higher than federal
·
'''[[USLegal:Schedule V|Schedule V controlled substance]] in US (federally)''', distinct from gabapentin which remains federally unscheduled'"`UNIQ--ref-00000028-QINU`"'
·
5-MeO-DMT is Schedule I in US (since 2011); the toad itself is protected in several southwestern states
·
Currently legal in most jurisdictions with thujone limits
·
Investigational
·
Leaves legal in Bolivia, Peru, Colombia; cocaine internationally controlled
·
Not a controlled substance in the United States, European Union, United Kingdom, Canada, or Australia. Prescription-only in all of these jurisdictions due to the narrow therapeutic index and the need for serum monitoring. No abuse potential has been identified.
Other values:
OTC (1% shampoo) and [[USLegal:Prescription only|Rx-only]] (higher strengths, oral) in US. Oral form carries a '''Boxed Warning''' for hepatotoxicity and is restricted by FDA to refractory fungal infections where no alternatives are available
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`"'
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Drilldown: Medicines
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