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Mydayis

(dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulfate)

Mydayis (mixed salts of a single-entity amphetamine product); CII

Full Prescribing Information DailyMed Drug Information

Summary

Mydayis is a triple-bead extended-release amphetamine capsule approved for ADHD from age 13, carrying the same four salts and 3:1 dextro to levo ratio as Adderall XR. An immediate-release bead plus two delayed-release beads unlocking at pH 5.5 and pH 7.0 give the longest coverage of any oral amphetamine here. Choose it when an adolescent needs late-evening rather than school-day coverage; it is ruled out below 13, where no safe and effective dose could be established. Schedule II; brand and generic.

Forms & Strengths

  • Extended-release capsules: 12.5 mg, 25 mg, 37.5 mg, 50 mg

Dosing

  • Age: ≥ 13 y/o; not established at 12 years and younger
  • Onset: 2-4 hours to measurable effect
  • Duration: up to 16 hours
  • Release Profile: Triple bead; one immediate-release plus two delayed-release beads releasing at pH 5.5 and pH 7.0. Tmax 7-10 hours pediatric, about 8 hours adult
  • Initial Dose:
    • 13-17 y/o: 12.5 mg once daily on awakening
    • 18-55 y/o: 12.5 mg once daily on awakening; 25 mg may be considered
    • Severe renal impairment (GFR 15 to < 30), adults: 12.5 mg once daily. ESRD not recommended at any age
  • Titration: 12.5 mg no sooner than weekly, at any age
  • Max Dose:
    • 13-17 y/o: 25 mg/day; above 25 mg not evaluated in pediatric trials. Severe renal impairment: 12.5 mg/day
    • 18-55 y/o: 50 mg/day; no additional benefit above 50 mg. Severe renal impairment: 25 mg/day
    • No dosing recommendation above age 55
  • Considerations: Give on awakening; effect may last 16 hours. Take consistently with or without food, since a high-fat meal delays Tmax 4.5 to 5 hours. A missed dose is skipped.

Pharmacology

  • Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component is what distinguishes amphetamines from methylphenidate
  • Delivery / Release: Two pH triggers rather than a timed matrix stage the second and third releases down the gut
  • Formulation: Four salts in equal weight, 3:1 dextro to levo. Linear over 12.5 to 50 mg, steady state days 7 to 8
  • Metabolism: CYP2D6 to 4-hydroxyamphetamine. Half-life 10-11 h d-amphetamine, 10-13 h l-amphetamine. Renal excretion is pH dependent
  • Pharmacogenomics: No genotype-directed dosing in the label; the actionable consequence is the CYP2D6-inhibitor interaction
  • Class Positioning: Same salts as Adderall XR plus a third pH 7.0 bead, extending 12 hours to 16, at the cost of the age-13 floor. Uniquely pH-dependent, so alkalinizers and PPIs matter more

Indications

  • ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 13 y/o. The only approved indication.

Off-Label Uses

  • ADHD in children 6 to 12 (ICD-10: F90.x): studied in two trials and rejected; negative on dose-finding. Use Adderall XR instead.
  • Narcolepsy (ICD-10: G47.419): off-label at every age; insufficient. Use an approved product: Adderall, Zenzedi, Dexedrine Spansule.
  • Binge eating disorder (ICD-10: F50.81): lisdexamfetamine holds this indication, adults only; insufficient here.
  • Where the evidence does not support use: depression augmentation; no pediatric evidence for triple-bead mixed salts (AHRQ 2024).
  • Cognitive enhancement without ADHD: not an indication; not supported.

Contraindications & Warnings

  • Boxed Warning: Abuse, misuse, and addiction; misuse can cause overdose and death. Assess abuse risk before prescribing and monitor frequently throughout.
  • Contraindicated:
    • Known hypersensitivity to amphetamine products or any ingredient in Mydayis
    • MAOI use, current or within 14 days
  • Use with caution (label Warnings, not contraindications):
    • Structural cardiac abnormality, cardiomyopathy or serious arrhythmia; the label says avoid
    • Pre-existing hypertension; blood pressure and heart rate rise
    • Psychosis or bipolar disorder
    • Prior seizure or EEG abnormality
    • Peripheral vasculopathy including Raynaud phenomenon
    • Tics or Tourette syndrome, personal or family
    • Substance use disorder, patient or household
    • Severe renal impairment; start and maximum both halve, ESRD not recommended
    • Settings where substitution error is likely; the label carries a dedicated overdose warning
  • Screen before starting:
    • Cardiac and family history of sudden death or ventricular arrhythmia; ECG only if positive
    • Tics, Tourette syndrome and mania risk factors, including family history
    • Abuse and diversion risk
    • Baseline height, weight, blood pressure and heart rate
    • Baseline sleep pattern, before adding a 16-hour agent

Drug Interactions

  • MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, IV methylene blue): hypertensive crisis; do not give within 14 days.
  • Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, buspirone, St John's Wort): serotonin syndrome; counsel on symptoms and stop both if it occurs.
  • CYP2D6 inhibitors (fluoxetine, paroxetine, bupropion, quinidine): raise exposure; start lower and monitor at each increase.
  • Alkalinizing agents (sodium bicarbonate, acetazolamide): raise levels and can unlock the beads early; avoid.
  • Acidifying agents (ascorbic acid, fruit juices): lower levels; adjust on response, not assumed failure.
  • Proton pump inhibitors (omeprazole): raise gastric pH and shift Tmax earlier; adjust timing.
  • Alcohol: in vitro, 20% and especially 40% alcohol increased release from the capsule; counsel on dose dumping.

Administration

  • Once daily on awakening; up to 16 hours of effect means later dosing costs sleep.
  • Take consistently with food or without, never alternating.
  • Swallow whole, or sprinkle the entire contents on applesauce, eaten immediately without chewing. Do not store.
  • Do not divide a capsule; sprinkling is a swallowing accommodation, not a dose split.
  • If a dose is missed, skip it and resume the next morning; never make it up.
  • Switching from another amphetamine: stop it and titrate from 12.5 mg weekly. No milligram-for-milligram conversion exists.
  • Store securely, preferably locked.

Side Effects

  • Common, 13 to 17: decreased appetite 22%, insomnia 8%, nausea 8%, irritability 6%, decreased weight 5%, dizziness 4%, upper abdominal pain 4%
  • Common, adults: insomnia 31%, decreased appetite 30%, weight decreased 9%, anxiety 7%, depression 3%, bruxism 2%
  • Serious:
    • Sudden death with structural cardiac disease. Investigate exertional chest pain or syncope immediately.
    • Psychosis, mania and new aggression. Consider discontinuing.
    • Serotonin syndrome. Stop both drugs and treat supportively.
    • Seizures. Discontinue.
    • Peripheral vasculopathy with digital ulceration. Reduce or stop; refer if persistent.
    • Growth suppression. Interrupt if height or weight gain falls behind.
    • New or worsening motor and verbal tics. Discontinue if clinically appropriate.
    • Overdose from substitution error between amphetamine products.

Monitoring & Labs

  • Cardiovascular: heart rate and blood pressure at baseline, each dose change, and every 6 months; act above the age-specific 95th percentile.
  • Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if the adolescent crosses two major percentile lines.
  • Sleep: at every visit and dose change, asking specifically about sleep-onset latency.
  • Appetite and weight: at every visit and every dose change.
  • Psychiatric and tics: psychosis, mania, aggression, irritability and new tics at every visit.
  • Peripheral vasculopathy: inspect fingers and toes at every visit.
  • Abuse and Diversion: adherence, pill counts and PDMP check at every refill.
  • Renal function: at baseline where impairment is suspected, and annually.
  • Laboratory: none routinely.

Discontinuation & Taper

  • May be stopped abruptly at therapeutic doses; no taper is required.
  • Withdrawal after abrupt stop following prolonged use: dysphoria, fatigue, vivid dreams, increased appetite.
  • Rebound irritability and hunger land late in the evening with a 16-hour agent, not after school.
  • Interrupt treatment where growth or weight gain falls behind.
  • Drug holidays fit poorly here; where appetite or growth is limiting, switch to a shorter product instead.

Pregnancy & Lactation

  • Pregnancy: Data insufficient to inform a risk of major birth defects or miscarriage. Premature delivery and low birth weight reported. Monitor exposed newborns for withdrawal.
  • Lactation: Label says breastfeeding is not recommended. Relative infant dose 2 to 13.8%, milk/plasma ratio 1.9 to 7.5; no reported infant adverse effects.
  • Milk supply: Dose-related prolactin suppression up to 40% may impair production before lactation is established. (LactMed 2025)
  • Exposure Registry: National Pregnancy Registry for Psychiatric Medications, 1-866-961-2388.

Counseling Points

  • Counsel the family on:

    • The 16-hour duration is both the reason for choosing it and the reason to watch sleep in week one.
    • Dosing on waking every day and never taking a missed dose later; a noon dose is a sleepless night.
    • Taking it the same way daily, with or without food, because switching moves the peak by about five hours.
    • Alcohol releases amphetamine faster from this capsule in laboratory testing.
    • Antacids and reflux medicines change when the later beads open, because they unlock on gut pH.
    • Never swapping this for another amphetamine capsule at the same milligrams; Mydayis 37.5 mg is not Adderall XR 37.5 mg.
    • Sprinkling being a swallowing accommodation, not a dose split.
    • Locked storage; sharing or selling a Schedule II medication is a felony.

  • Advise them to call for:

    • Chest pain on exertion, fainting, or a racing heart that does not settle.
    • New hallucinations, or new suspicious or fearful thinking.
    • Numbness, coldness or colour change in the fingers or toes.
    • A new or markedly worse tic, or a seizure of any kind.
    • Falling asleep after 1 am on more than a night or two.
    • Weight loss, or clothes fitting more loosely over a few weeks.
    • Agitation, shivering, sweating or confusion after an antidepressant change.

References

  1. DailyMed. MYDAYIS (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate) extended-release capsules prescribing information. Takeda Pharmaceuticals America. Revised 4/2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=141a7970-3f06-44ea-9ab7-aeece2c085fc
  2. LactMed. Amphetamine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/
  3. openFDA. NDC Directory, generic_name "amphetamine aspartate". US Food and Drug Administration. 2026. https://api.fda.gov/drug/ndc.json
  4. Agency for Healthcare Research and Quality. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
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