ビロキサジン塩酸塩

id: viloxazine
brandNames:
  US:
    - Qelbree
  CN: []
  EU: []
  JP: []
  UK: []
  AU: []
  CA: []
genericName:
  en: viloxazine hydrochloride
  zh: 盐酸维洛沙嗪
  ja: ビロキサジン塩酸塩
manufacturers:
  - name: Supernus Pharmaceuticals
    region: US
    product: Qelbree
chemicalStructure:
  smiles: CCOC1=CC=CC=C1OCC2CNCCO2
  pubchemCid: 5666
  molecularFormula: C13H19NO3
  imageUrl: https://pubchem.ncbi.nlm.nih.gov/rest/pug/compound/cid/5666/PNG
  wikipediaUrl: https://en.wikipedia.org/wiki/File:Viloxazine.svg
drugClass: non-stimulant
drugClassLabel:
  en: Non-Stimulant
  zh: 非兴奋剂
  ja: 非中枢刺激薬
category: SNRI (selective norepinephrine reuptake inhibitor)
categoryLabel:
  en: Selective Norepinephrine Reuptake Inhibitor
  zh: 选择性去甲肾上腺素再摄取抑制剂
  ja: 選択的ノルエピネフリン再取り込み阻害薬
controlledSubstance: false
schedule:
  US: Not scheduled
  CN: Not approved
  EU: Not approved
  JP: Not approved
  UK: Not approved
activeIngredient:
  en: viloxazine hydrochloride
  zh: 盐酸维洛沙嗪
  ja: ビロキサジン塩酸塩
mechanismOfAction:
  en: Selective norepinephrine reuptake inhibitor with additional serotonergic activity (5-HT2B receptor antagonism and 5-HT2C receptor modulation). Increases norepinephrine levels in the prefrontal cortex to improve attention and executive function.
  zh: 选择性去甲肾上腺素再摄取抑制剂，具有额外的血清素能活性（5-HT2B受体拮抗和5-HT2C受体调节）。增加前额叶皮层去甲肾上腺素水平，改善注意力和执行功能。
  ja: 選択的ノルエピネフリン再取り込み阻害薬で、セロトニン作動活性も有する（5-HT2B受容体拮抗および5-HT2C受容体調節）。前頭前皮質のノルエピネフリン濃度を上昇させ、注意力と実行機能を改善します。
neurotransmittersAffected:
  - norepinephrine
  - serotonin
forms:
  - type: capsule
    typeLabel:
      en: Capsule
      zh: 胶囊
      ja: カプセル
    releaseType: extended
    releaseTypeLabel:
      en: Extended Release
      zh: 缓释
      ja: 徐放性
    brandName: Qelbree
    strengths:
      - 100mg
      - 150mg
      - 200mg
    durationHours: 24
    notes:
      en: "Children 6-11: 100-400mg; can be opened and sprinkled on applesauce"
      zh: 6-11岁儿童：100-400mg；可打开撒在苹果酱上
      ja: 6〜11歳の小児：100〜400mg；カプセルを開けてアップルソースにふりかけることができます
  - type: capsule
    typeLabel:
      en: Capsule
      zh: 胶囊
      ja: カプセル
    releaseType: extended
    releaseTypeLabel:
      en: Extended Release
      zh: 缓释
      ja: 徐放性
    brandName: Qelbree
    strengths:
      - 200mg
      - 400mg
      - 600mg
    durationHours: 24
    notes:
      en: "Adolescents 12-17 and adults: 200-600mg"
      zh: 12-17岁青少年和成人：200-600mg
      ja: 12〜17歳の青年および成人：200〜600mg
onsetMinutes:
peakEffectHours: 5
durationHours: 24
sideEffects:
  common:
    - name:
        en: somnolence/fatigue
        zh: 嗜睡/疲劳
        ja: 傾眠/疲労
      frequency: 15-20%
    - name:
        en: decreased appetite
        zh: 食欲下降
        ja: 食欲減退
      frequency: 10-15%
    - name:
        en: nausea
        zh: 恶心
        ja: 悪心
      frequency: 10-15%
    - name:
        en: headache
        zh: 头痛
        ja: 頭痛
      frequency: 10%
    - name:
        en: irritability
        zh: 易怒
        ja: 易刺激性
      frequency: 5-10%
    - name:
        en: vomiting
        zh: 呕吐
        ja: 嘔吐
      frequency: 5-10%
    - name:
        en: insomnia
        zh: 失眠
        ja: 不眠
      frequency: 5%
  uncommon:
    - name:
        en: abdominal pain
        zh: 腹痛
        ja: 腹痛
      frequency: 5%
    - name:
        en: tachycardia
        zh: 心动过速
        ja: 頻脈
      frequency: <5%
    - name:
        en: increased blood pressure
        zh: 血压升高
        ja: 血圧上昇
      frequency: <5%
    - name:
        en: weight loss
        zh: 体重减轻
        ja: 体重減少
      frequency: <5%
  serious:
    - name:
        en: suicidal ideation
        zh: 自杀意念
        ja: 自殺念慮
      notes:
        en: Black box warning; monitor closely, especially early in treatment
        zh: 黑框警告；需密切监测，尤其是治疗初期
        ja: ブラックボックス警告；特に治療初期は注意深くモニタリングが必要
    - name:
        en: activation of mania/hypomania
        zh: 诱发躁狂/轻躁狂
        ja: 躁病/軽躁病の誘発
      notes:
        en: Can trigger in susceptible patients
        zh: 易感患者可能诱发
        ja: 感受性の高い患者で誘発される可能性
    - name:
        en: serotonin syndrome
        zh: 血清素综合征
        ja: セロトニン症候群
      notes:
        en: When combined with serotonergic medications
        zh: 与血清素能药物联用时
        ja: セロトニン作動薬との併用時
    - name:
        en: hypertensive crisis
        zh: 高血压危象
        ja: 高血圧クリーゼ
      notes:
        en: Avoid with MAOIs
        zh: 避免与MAO抑制剂联用
        ja: MAOIとの併用を避ける
contraindications:
  en:
    - Hypersensitivity to viloxazine
    - MAO inhibitor use within 14 days
    - Concomitant use of sensitive CYP1A2 substrates (e.g., tizanidine, alosetron)
  zh:
    - 对维洛沙嗪过敏
    - 14天内使用过MAO抑制剂
    - 同时使用敏感的CYP1A2底物（如替扎尼定、阿洛司琼）
  ja:
    - ビロキサジンに対する過敏症
    - 14日以内のMAO阻害剤使用
    - 感受性の高いCYP1A2基質との併用（例：チザニジン、アロセトロン）
drugInteractions:
  - drug:
      en: MAO inhibitors
      zh: MAO抑制剂
      ja: MAO阻害剤
    severity: major
    effect:
      en: Risk of serotonin syndrome and hypertensive crisis
      zh: 血清素综合征和高血压危象风险
      ja: セロトニン症候群および高血圧クリーゼのリスク
  - drug:
      en: CYP1A2 substrates (theophylline, duloxetine)
      zh: CYP1A2底物（茶碱、度洛西汀）
      ja: CYP1A2基質（テオフィリン、デュロキセチン）
    severity: major
    effect:
      en: Significantly increases levels of CYP1A2 substrates
      zh: 显著增加CYP1A2底物血药浓度
      ja: CYP1A2基質の濃度を著しく上昇させる
  - drug:
      en: Serotonergic drugs
      zh: 血清素能药物
      ja: セロトニン作動薬
    severity: moderate
    effect:
      en: Increased serotonin syndrome risk
      zh: 血清素综合征风险增加
      ja: セロトニン症候群リスクの増加
  - drug:
      en: Seizure threshold-lowering drugs
      zh: 降低癫痫阈值的药物
      ja: 発作閾値を下げる薬物
    severity: moderate
    effect:
      en: May increase seizure risk
      zh: 可能增加癫痫发作风险
      ja: 発作リスクを増加させる可能性
blackBoxWarnings:
  en:
    - Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults
  zh:
    - 儿童、青少年和年轻成人自杀想法和行为风险增加
  ja:
    - 小児、青年、若年成人における自殺念慮および自殺行動のリスク増加
pregnancyCategory: C
foodInteractions:
  en: Can be taken with or without food
  zh: 可随餐或空腹服用
  ja: 食事の有無にかかわらず服用可能
typicalDosing:
  children:
    startingDose: 100mg once daily in morning
    maxDose: 400mg/day (ages 6-11)
    notes:
      en: May increase by 100mg weekly
      zh: 可每周增加100mg
      ja: 毎週100mgずつ増量可能
  adults:
    startingDose: 200mg once daily in morning
    maxDose: 600mg/day
    notes:
      en: May increase by 200mg weekly
      zh: 可每周增加200mg
      ja: 毎週200mgずつ増量可能
costEstimate:
  US:
    brand: $350-450/month
    generic: Not yet available
  CN:
    brand: Not available
    generic: Not available
storageRequirements:
  en: Room temperature (20-25°C)
  zh: 室温保存（20-25°C）
  ja: 室温（20-25°C）で保存
approvals:
  - region: US
    agency: FDA
    year: 2021
    approvedAges:
      en: 6 years and older (children and adults)
      zh: 6岁及以上（儿童和成人）
      ja: 6歳以上（小児および成人）
    indications:
      en:
        - ADHD
      zh:
        - 注意缺陷多动障碍
      ja:
        - ADHD
    available: true
    notes:
      en: Children ages 6-11 approved April 2021; adults approved April 2022
      zh: 6-11岁儿童于2021年4月获批；成人于2022年4月获批
      ja: 6〜11歳の小児は2021年4月承認；成人は2022年4月承認
  - region: CN
    agency: NMPA
    year:
    approvedAges:
      en: ""
      zh: ""
      ja: ""
    indications:
      en: []
      zh: []
      ja: []
    available: false
    notes:
      en: Not approved
      zh: 未批准
      ja: 未承認
  - region: EU
    agency: EMA
    year:
    approvedAges:
      en: ""
      zh: ""
      ja: ""
    indications:
      en: []
      zh: []
      ja: []
    available: false
    notes:
      en: Not approved (was previously marketed for depression in EU in 1970s-1980s)
      zh: 未批准（20世纪70-80年代曾在欧盟作为抗抑郁药销售）
      ja: 未承認（1970〜1980年代にEUでうつ病薬として販売されていた）
  - region: JP
    agency: PMDA
    year:
    approvedAges:
      en: ""
      zh: ""
      ja: ""
    indications:
      en: []
      zh: []
      ja: []
    available: false
    notes:
      en: Not approved
      zh: 未批准
      ja: 未承認
  - region: UK
    agency: MHRA
    year:
    approvedAges:
      en: ""
      zh: ""
      ja: ""
    indications:
      en: []
      zh: []
      ja: []
    available: false
    notes:
      en: Not approved
      zh: 未批准
      ja: 未承認
specialConsiderations:
  cardiacRisk:
    en: Can increase heart rate and blood pressure; monitor
    zh: 可增加心率和血压；需监测
    ja: 心拍数と血圧を上昇させる可能性；モニタリングが必要
  abuseRisk:
    en: No abuse potential; not a controlled substance
    zh: 无滥用风险；非管制药物
    ja: 乱用の可能性なし；規制物質ではない
  withdrawalNotes:
    en: No significant withdrawal; can be stopped without tapering
    zh: 无明显戒断症状；可直接停药无需减量
    ja: 重大な離脱症状なし；漸減なしで中止可能
  monitoringRequired:
    en: Monitor for suicidality, especially early; blood pressure; heart rate
    zh: 监测自杀倾向（尤其是初期）；血压；心率
    ja: 自殺傾向のモニタリング（特に初期）；血圧；心拍数
travelRules:
  generalAdvice:
    en: Viloxazine is NOT a controlled substance. However, it is currently ONLY approved in the US, so availability abroad is very limited. Plan accordingly for longer trips.
    zh: 维洛沙嗪不是管制药物。但目前仅在美国获批，国外供应非常有限。长途旅行请提前规划。
    ja: ビロキサジンは規制物質ではありません。ただし、現在は米国でのみ承認されているため、海外での入手可能性は非常に限られています。長期旅行の場合は事前に計画してください。
  requiredDocumentation:
    - type: prescription
      typeLabel:
        en: Valid prescription
        zh: 有效处方
        ja: 有効な処方箋
      notes:
        en: Carry prescription as viloxazine is not recognized in most countries
        zh: 携带处方，因为维洛沙嗪在大多数国家不被认可
        ja: ビロキサジンはほとんどの国で認知されていないため、処方箋を携帯
    - type: medical_letter
      typeLabel:
        en: Doctor's letter
        zh: 医生证明信
        ja: 医師の診断書
      notes:
        en: Explaining the medication since it's US-only
        zh: 说明药物用途，因为仅在美国上市
        ja: 米国のみで利用可能な薬であることを説明
  maxPersonalSupply:
    default: 90 days
  crossBorderRules:
    - fromRegion: US
      toRegion: JP
      status: restricted
      statusLabel:
        en: Restricted - Not Available Locally
        zh: 受限 - 当地不可用
        ja: 制限あり - 現地で入手不可
      requirements:
        en:
          - Carry prescription and doctor's letter
          - Keep in original packaging
          - Bring sufficient supply
        zh:
          - 携带处方和医生证明信
          - 保持原包装
          - 携带充足的供应量
        ja:
          - 処方箋と医師の手紙を携帯
          - 元のパッケージを維持
          - 十分な量を持参
      maxSupply: 90 days
      notes:
        en: Viloxazine is NOT approved in Japan. You can bring personal supply but cannot obtain refills. Consider this for longer stays.
        zh: 维洛沙嗪在日本未获批准。可以携带个人使用量，但无法补充。长期停留请考虑此问题。
        ja: ビロキサジンは日本では未承認です。個人使用分は持ち込めますが、補充はできません。長期滞在の場合はご注意ください。
    - fromRegion: US
      toRegion: CN
      status: restricted
      statusLabel:
        en: Restricted - Not Available Locally
        zh: 受限 - 当地不可用
        ja: 制限あり - 現地で入手不可
      requirements:
        en:
          - Carry prescription and doctor's letter
          - Keep in original packaging
        zh:
          - 携带处方和医生证明信
          - 保持原包装
        ja:
          - 処方箋と医師の手紙を携帯
          - 元のパッケージを維持
      maxSupply: 90 days
      notes:
        en: Viloxazine is NOT approved in China. Personal import for personal use may be allowed with documentation.
        zh: 维洛沙嗪在中国未获批准。携带文件的个人使用进口可能被允许。
        ja: ビロキサジンは中国では未承認です。書類があれば個人使用の輸入は許可される場合があります。
    - fromRegion: US
      toRegion: EU
      status: restricted
      statusLabel:
        en: Restricted - Not Available Locally
        zh: 受限 - 当地不可用
        ja: 制限あり - 現地で入手不可
      requirements:
        en:
          - Carry prescription and doctor's letter
          - Keep in original packaging
        zh:
          - 携带处方和医生证明信
          - 保持原包装
        ja:
          - 処方箋と医師の手紙を携帯
          - 元のパッケージを維持
      maxSupply: 90 days
      notes:
        en: Viloxazine is NOT approved in EU. Was previously marketed for depression in 1970s-80s but withdrawn. Personal supply for travel should be allowed.
        zh: 维洛沙嗪在欧盟未获批准。20世纪70-80年代曾作为抗抑郁药销售但已撤市。旅行携带个人使用量应该被允许。
        ja: ビロキサジンはEUでは未承認です。1970〜80年代にうつ病薬として販売されていましたが撤退。旅行用の個人使用分は許可されるはずです。
rxnormData:
  ingredientRxcui: "11196"
  ingredientName: viloxazine
  rxcuiMappings:
    - rxcui: "11196"
      name: viloxazine
      tty: IN
      description: Base ingredient
    - rxcui: "2536549"
      name: Qelbree
      tty: BN
      description: Brand name
    - rxcui: "142143"
      name: viloxazine hydrochloride
      tty: PIN
      description: Precise ingredient (includes salt form)
    - rxcui: "2536554"
      name: 24 HR viloxazine 100 MG Extended Release Oral Capsule [Qelbree]
      tty: SBD
      description: Branded drug (brand + strength + form)
    - rxcui: "2536752"
      name: 24 HR viloxazine 150 MG Extended Release Oral Capsule [Qelbree]
      tty: SBD
      description: Branded drug (brand + strength + form)
    - rxcui: "2536758"
      name: 24 HR viloxazine 200 MG Extended Release Oral Capsule [Qelbree]
      tty: SBD
      description: Branded drug (brand + strength + form)
    - rxcui: "2536551"
      name: viloxazine Extended Release Oral Capsule [Qelbree]
      tty: SBDF
      description: Branded ingredient + dose form
    - rxcui: "2536548"
      name: 24 HR viloxazine 100 MG Extended Release Oral Capsule
      tty: SCD
      description: Clinical drug (ingredient + strength + form)
    - rxcui: "2536750"
      name: 24 HR viloxazine 150 MG Extended Release Oral Capsule
      tty: SCD
      description: Clinical drug (ingredient + strength + form)
    - rxcui: "2536756"
      name: 24 HR viloxazine 200 MG Extended Release Oral Capsule
      tty: SCD
      description: Clinical drug (ingredient + strength + form)
    - rxcui: "2536547"
      name: viloxazine Extended Release Oral Capsule
      tty: SCDF
      description: Ingredient + dose form
  brandMappings:
    - brandName: Qelbree
      rxcui: "2536549"
      region: US
  synonyms:
    - name: viloxazine hydrochloride
      type: chemical
      source: RxNorm
    - name: Qelbree
      type: brand
      source: RxNorm
    - name: viloxazine
      type: generic
      source: RxNorm
  relatedDrugs:
    - rxcui: "2536548"
      name: 24 HR viloxazine 100 MG Extended Release Oral Capsule
      tty: SCD
      relationship: clinical_drug
    - rxcui: "2536750"
      name: 24 HR viloxazine 150 MG Extended Release Oral Capsule
      tty: SCD
      relationship: clinical_drug
    - rxcui: "2536756"
      name: 24 HR viloxazine 200 MG Extended Release Oral Capsule
      tty: SCD
      relationship: clinical_drug
    - rxcui: "2536554"
      name: 24 HR viloxazine 100 MG Extended Release Oral Capsule [Qelbree]
      tty: SBD
      relationship: branded_drug
    - rxcui: "2536752"
      name: 24 HR viloxazine 150 MG Extended Release Oral Capsule [Qelbree]
      tty: SBD
      relationship: branded_drug
    - rxcui: "2536758"
      name: 24 HR viloxazine 200 MG Extended Release Oral Capsule [Qelbree]
      tty: SBD
      relationship: branded_drug
    - rxcui: "2536547"
      name: viloxazine Extended Release Oral Capsule
      tty: SCDF
      relationship: drug_form
  lastUpdated: 2025-12-04
instructions:
  indicationsAndUsage:
    en: |
      Viloxazine extended-release (Qelbree) is a selective norepinephrine reuptake inhibitor indicated for the treatment of:
      - Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older

      Viloxazine is a non-stimulant medication with additional serotonergic activity. It was previously used in Europe for depression in the 1970s-1980s and has been repurposed for ADHD.
  dosageAndAdministration:
    en: |
      CHILDREN (6-11 YEARS):
      - Starting dose: 100 mg once daily in the morning
      - May increase by 100 mg weekly to optimal response
      - Maximum dose: 400 mg/day

      ADOLESCENTS (12-17 YEARS):
      - Starting dose: 200 mg once daily in the morning
      - May increase by 200 mg weekly to optimal response
      - Maximum dose: 400 mg/day

      ADULTS (18+ YEARS):
      - Starting dose: 200 mg once daily in the morning
      - May increase by 200 mg weekly to optimal response
      - Target dose: 200-600 mg/day
      - Maximum dose: 600 mg/day

      General Instructions:
      - Take once daily in the morning with or without food
      - Capsules may be opened and entire contents sprinkled on applesauce
      - If sprinkled: consume immediately, do not chew, do not store
      - Swallow whole if possible

      HEPATIC IMPAIRMENT:
      - Severe (Child-Pugh C): Maximum dose reduced by 50%

      RENAL IMPAIRMENT:
      - Severe (eGFR <30): Maximum dose reduced by 50%
      - ESRD: Maximum dose reduced by 50%
  dosageForms:
    en: |
      Extended-Release Capsules (Qelbree):
      - Children/Adolescents: 100 mg, 150 mg, 200 mg
      - Adults: 200 mg, 400 mg, 600 mg
  contraindications:
    en: |
      Viloxazine is contraindicated in patients:
      - With known hypersensitivity to viloxazine or any components
      - Receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping an MAOI
      - Starting MAOIs within 14 days of stopping viloxazine
      - Receiving concomitant treatment with sensitive CYP1A2 substrates or substrates with narrow therapeutic range
  warningsAndPrecautions:
    en: |
      SUICIDAL THOUGHTS AND BEHAVIORS:
      - Antidepressants increase risk of suicidal thinking and behavior in children, adolescents, and young adults
      - Monitor closely for clinical worsening and suicidality
      - Consider changing or discontinuing if significant changes occur
      - Note: Viloxazine was originally developed as an antidepressant

      BLOOD PRESSURE AND HEART RATE INCREASES:
      - Can cause increases in diastolic blood pressure and heart rate
      - Assess heart rate and blood pressure before treatment and periodically during treatment
      - Use caution in patients for whom increases may be problematic

      ACTIVATION OF MANIA/HYPOMANIA:
      - May precipitate mixed/manic episode in patients with bipolar disorder
      - Screen for bipolar disorder before initiating treatment

      SOMNOLENCE AND FATIGUE:
      - Common adverse reactions
      - May impair ability to drive or operate machinery
      - Assess before patients engage in potentially hazardous activities
  adverseReactions:
    en: |
      Most Common Adverse Reactions in Pediatric Patients (≥5%):
      - Somnolence (16-17%)
      - Decreased appetite (10-13%)
      - Fatigue (6-9%)
      - Nausea (6-8%)
      - Vomiting (4-7%)
      - Insomnia (4-6%)
      - Irritability (5%)

      Most Common Adverse Reactions in Adults (≥5%):
      - Insomnia (11%)
      - Fatigue (11%)
      - Nausea (10%)
      - Dry mouth (6%)
      - Constipation (6%)
      - Decreased appetite (6%)
      - Headache (5%)

      Other Notable Adverse Reactions:
      - Dizziness
      - Weight loss
      - Upper abdominal pain
      - Increased heart rate
  drugInteractions:
    en: |
      CONTRAINDICATED:
      - MAO Inhibitors: Do not use during or within 14 days of MAOI treatment
      - Sensitive CYP1A2 Substrates: May significantly increase exposure (e.g., alosetron, duloxetine, ramelteon, tasimelteon, theophylline, tizanidine)

      SIGNIFICANT INTERACTIONS:
      - CYP1A2 Substrates: Viloxazine is a strong CYP1A2 inhibitor; avoid or reduce dose of CYP1A2 substrates
      - Theophylline: Exposure increased 2-fold; consider dose reduction
      - Caffeine: Exposure may be increased; consider reducing caffeine intake

      USE WITH CAUTION:
      - Drugs affecting blood pressure or heart rate
      - Other serotonergic drugs (risk of serotonin syndrome)
  useInSpecificPopulations:
    en: |
      PREGNANCY:
      - Limited data in pregnant women
      - Based on animal studies, may cause fetal harm
      - Use only if potential benefit justifies risk

      LACTATION:
      - Unknown if excreted in human milk
      - Consider developmental benefits of breastfeeding along with mother's clinical need

      PEDIATRIC USE:
      - Safety and efficacy established for patients 6 years and older
      - Not studied in children under 6 years

      GERIATRIC USE:
      - Clinical studies did not include sufficient patients 65 and older

      HEPATIC IMPAIRMENT:
      - Severe impairment (Child-Pugh C): Maximum dose reduced by 50%

      RENAL IMPAIRMENT:
      - Severe impairment (eGFR <30 mL/min): Maximum dose reduced by 50%
      - ESRD: Maximum dose reduced by 50%
  overdosage:
    en: |
      SIGNS AND SYMPTOMS:
      - Limited information available
      - Expected symptoms based on pharmacology: somnolence, drowsiness, increased heart rate, elevated blood pressure

      TREATMENT:
      - No specific antidote
      - Provide supportive care
      - Monitor cardiac and vital signs
      - Consider gastric lavage if recent ingestion
      - Activated charcoal may be useful
      - Contact Poison Control Center (1-800-222-1222)
  clinicalPharmacology:
    en: |
      MECHANISM OF ACTION:
      The mechanism by which viloxazine produces therapeutic effects in ADHD is unclear. Viloxazine is:
      - A selective norepinephrine reuptake inhibitor (SNRI)
      - A 5-HT2B receptor antagonist
      - A 5-HT2C receptor modulator

      This combination of actions distinguishes it from atomoxetine and may contribute to its efficacy profile.

      Note: Viloxazine was originally marketed in Europe as an antidepressant (1970s-1980s) but was withdrawn and later repurposed for ADHD.

      PHARMACOKINETICS:
      - Absorption: Well absorbed; peak concentration at 5 hours
      - Distribution: Plasma protein binding approximately 76-82%
      - Metabolism: Primarily hepatic via UGT1A9 and UGT2B15; CYP2D6 minor pathway
      - Half-life: Approximately 7 hours
      - Excretion: ~90% in urine (mainly as metabolites)
  howSupplied:
    en: |
      STORAGE AND HANDLING:
      - Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
      - Protect from moisture

      Not a Controlled Substance - No DEA Schedule
  patientCounselingInfo:
    en: |
      IMPORTANT PATIENT INFORMATION:

      1. SUICIDAL THOUGHTS: Watch for and report immediately any new or worsening depression, anxiety, agitation, panic attacks, irritability, hostility, or thoughts of self-harm.

      2. DOSING: Take once daily in the morning. Capsules may be opened and sprinkled on applesauce if needed. Consume immediately.

      3. DROWSINESS: This medication may cause drowsiness or fatigue. Avoid driving or operating machinery until you know how it affects you.

      4. HEART MONITORING: Blood pressure and heart rate will be checked regularly during treatment.

      5. CAFFEINE: This medication can increase the effects of caffeine. You may need to reduce caffeine intake.

      6. OTHER MEDICATIONS: Tell your doctor about all medications, especially MAO inhibitors, theophylline, and certain antidepressants.

      7. NOT A STIMULANT: This is a non-stimulant medication. It may take 1-2 weeks to notice effects and several weeks for full benefit.

      8. PREGNANCY/NURSING: Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

      9. US ONLY: This medication is currently only available in the United States. It is not approved in Europe, Japan, or China.

      10. MISSED DOSE: If you miss a dose in the morning, skip it. Do not take in the afternoon/evening. Resume the next morning.
lastUpdated: 2025-12-04
sources:
  - https://www.goodrx.com/conditions/adhd/non-stimulant-adhd-meds
  - https://www.additudemag.com/adhd-medications-list-chart-stimulants-nonstimulants/
  - https://medx.it.com/what-are-the-new-adhd-medications-in-2025-an-overview-of-treatments-and-innovations
notes:
  en: Newest non-stimulant option (2021). Structurally different from atomoxetine despite similar mechanism. Was previously used for depression in Europe (1970s-1980s) but withdrawn. Repurposed and FDA-approved for ADHD. Currently only available in US.
  zh: 最新的非兴奋剂选择（2021年）。尽管作用机制相似，但结构与托莫西汀不同。曾在20世纪70-80年代在欧洲用于抗抑郁但已撤市。重新定位并获FDA批准用于ADHD。目前仅在美国上市。
  ja: 最新の非刺激薬オプション（2021年）。同様の作用機序にもかかわらず、アトモキセチンとは構造が異なる。1970〜1980年代にヨーロッパでうつ病に使用されていたが撤退。ADHDに再利用されFDA承認。現在は米国でのみ利用可能。