{"id":"869ca79a-8410-4134-93fd-f2fbc7610dbf","legacy_id":"222","name":"Agomelatine","slug":"agomelatine","latin_name":null,"brand_names":null,"common_names":null,"abbreviation":null,"tcm_name":null,"ayurveda_name":null,"year_developed":null,"dosage_default":null,"dosage_min":null,"dosage_max":null,"dosage_daily":null,"dosage_notes":null,"tolerance_notes":null,"acute_effect_duration":null,"category":"synthetic-nootropics-research","composition":null,"listing_regex":"\\bagomelatine\\b","content":"\n\n<h1>Agomelatine: A Nootropic with Unique Properties</h1>\n\n<p>Agomelatine, also known as Valdoxan, is a nootropic drug used to treat depression and anxiety. It is a melatonin receptor agonist and a serotonin 5-HT2C receptor antagonist. Agomelatine has been found to have a number of positive effects on cognitive performance, including improved memory, focus, and concentration. It is also known to have a calming effect on the user, making it a popular choice for those looking to reduce stress and anxiety.</p>\n\n<h2>Positive Effects of Agomelatine</h2>\n\n<ul>\n  <li>Improved memory</li>\n  <li>Increased focus and concentration</li>\n  <li>Reduced stress and anxiety</li>\n  <li>Improved mood</li>\n  <li>Improved sleep quality</li>\n</ul>\n\n<h2>Possible Negative Effects of Agomelatine</h2>\n\n<ul>\n  <li>Headache</li>\n  <li>Nausea</li>\n  <li>Dizziness</li>\n  <li>Fatigue</li>\n  <li>Weight gain</li>\n</ul>\n\n<h2>Dosage Information</h2>\n\n<p>The recommended dosage of Agomelatine is 25-50 mg per day. It is important to consult with a doctor before taking any medication, as the dosage may vary depending on the individual's medical history and other medications they may be taking.</p>\n\n<h2>History of Agomelatine</h2>\n\n<p>Agomelatine was first developed in the early 2000s by the pharmaceutical company Servier. It was approved for use in Europe in 2009 and is now available in many countries around the world. Agomelatine has been found to be effective in treating depression and anxiety, and is now being studied for its potential to improve cognitive performance.</p>","version":null,"crawler_options":{},"spider":true,"enabled":true,"has_image":false,"listings_total":6,"listings_active":3,"search_text":"Agomelatine hormone","created_at":"2026-06-05T13:31:23.256Z","updated_at":"2026-06-05T14:00:41.994Z","supplementtags":[],"references":[],"related_articles":[],"profile_page":{"id":"1b9ff403-bf72-4389-b597-004ff1cc1a14","supplement_id":"869ca79a-8410-4134-93fd-f2fbc7610dbf","source_profile_id":"eabd1072-cb79-4b99-a7f3-3ee53cbe2304","form_of_supplement_id":null,"family_kind":"form","schema_version":2,"slug":"agomelatine","primary_display_name":"Agomelatine","canonical_identity_name":"Agomelatine","primary_category_key":"synthetic-nootropics-research","primary_category_name":"Synthetic nootropics & research compounds","accent_color":"#6b5bd9","seo_title":"Agomelatine (Valdoxan): evidence, safety and prices","seo_description":"Compare Agomelatine and Valdoxan listings by tablet strength and pack size, with clinical evidence, plasma timing, EU status and liver-safety cautions.","meta_robots":"index_follow","payload":{"seo":{"title":"Agomelatine (Valdoxan): evidence, safety and prices","metaRobots":"index_follow","description":"Compare Agomelatine and Valdoxan listings by tablet strength and pack size, with clinical evidence, plasma timing, EU status and liver-safety cautions."},"source":{"revision":3,"profileId":"eabd1072-cb79-4b99-a7f3-3ee53cbe2304","reviewedAt":"2026-10-19T19:35:25.464Z","generatedAt":"2026-10-19T19:35:30.363Z","reviewedRevision":3,"sourceProfileUpdatedAt":"2026-10-19T19:35:25.464Z","isCurrentRevisionReviewed":true},"aliases":[{"id":"83a747fb-ba52-4717-8c46-5f335f578050","notes":"Preferred INN/generic name.","value":"Agomelatine","typeKey":"common-name","typeName":"Common Name","referenceId":"6eca88bd-3b6c-41c2-afce-06300e7bc901"},{"id":"e9205cb5-7997-43d0-80ab-cb23e3277f89","notes":"EU brand name in EMA source and current indexed listings.","value":"Valdoxan","typeKey":"brand-name","typeName":"Brand Name","referenceId":"0bc1c8cf-7370-4b44-934c-e55faf69d6d1"},{"id":"fd883441-aea5-4a6d-b558-a168c9d9c2bf","notes":"PubChem/clinical-review synonym and market name.","value":"Thymanax","typeKey":"brand-name","typeName":"Brand Name","referenceId":"6eca88bd-3b6c-41c2-afce-06300e7bc901"},{"id":"18e9730f-0827-4287-9d14-7b699cc899c1","notes":"Indexed product name context.","value":"Agoprex","typeKey":"brand-name","typeName":"Brand Name","referenceId":"f6bf1cae-57e6-415e-a8c8-9f744e28d5e6"},{"id":"bc780792-a338-4dcd-a6ac-79aa1d7ce5db","notes":"Research code synonym.","value":"S-20098","typeKey":"research-code","typeName":"Research Code","referenceId":"6eca88bd-3b6c-41c2-afce-06300e7bc901"},{"id":"8170f911-11da-4e30-9dee-494415ae8f0c","notes":"IUPAC name.","value":"N-[2-(7-methoxynaphthalen-1-yl)ethyl]acetamide","typeKey":"iupac-name","typeName":"Iupac Name","referenceId":"6eca88bd-3b6c-41c2-afce-06300e7bc901"}],"profile":{"onsetText":null,"dosageUnit":null,"timingText":null,"quickAnswer":"Agomelatine (Valdoxan) is an EU-authorised prescription antidepressant for major depressive episodes in adults. Depression evidence does not establish memory, focus or productivity benefits in healthy users. Compare finished-tablet identity, strength and pack size before price. The high risk rating reflects an established oral liver hazard and required monitoring under the EU label, not a healthy-user incidence estimate. Approval and dispensing rules vary by jurisdiction.","durationText":null,"halfLifeText":"1-2 hours","dosageMaxValue":null,"dosageMinValue":null,"evidenceSummary":"Agomelatine has regulatory and clinical evidence for major depressive episodes in adults, but the effect is condition-specific and the trial record is not uniformly positive. EMA notes mixed placebo-controlled results and says benefits may be lower than with some other antidepressants; a large 2018 network meta-analysis nevertheless found agomelatine and the other included antidepressants more efficacious than placebo, with certainty ranging from moderate to very low across comparisons. No comparable evidence establishes memory, focus, productivity, or acute mood enhancement in healthy users. Liver monitoring and prescription oversight are inseparable from the evidence-based use case.","effectTimingMode":"cumulative","overallRiskLabel":"High risk","overallRiskLevel":"high","overallRiskScore":4,"shortDescription":"Prescription melatonergic antidepressant with adult-depression evidence, unestablished nootropic benefit and mandatory liver monitoring under its EU label.","bestResearchedFor":["Adult major-depression outcomes in prescription clinical trials","Depression symptom changes measured over weeks","Sleep-pattern measures and relapse prevention within depression studies"],"typicalDosageText":null,"limitedEvidenceFor":["Memory, focus and productivity benefits in healthy users","A reliable single-dose nootropic effect or recommended consumer cycle","Healthy-adult unsupervised safety or use without liver monitoring"],"overallEvidenceGrade":"B","overallEvidenceLabel":"Adult depression evidence; no established nootropic benefit"},"identity":{"slug":"agomelatine","category":{"key":"synthetic-nootropics-research","name":"Synthetic nootropics & research compounds","accentColor":"#6b5bd9"},"profileCode":"AGOM","secondaryTags":[{"key":"sleep-support","name":"Sleep Support","groupKey":"effect","groupName":"Effect tags"},{"key":"mood-support","name":"Mood Support","groupKey":"effect","groupName":"Effect tags"},{"key":"dopaminergic","name":"Dopaminergic","groupKey":"mechanism-system","groupName":"Mechanism/system tags"},{"key":"serotonergic","name":"Serotonergic","groupKey":"mechanism-system","groupName":"Mechanism/system tags"},{"key":"synthetic","name":"Synthetic","groupKey":"source-form","groupName":"Source/form tags"},{"key":"clinical-research","name":"Clinical Research","groupKey":"tradition-context","groupName":"Tradition/context tags"},{"key":"high-risk-profile","name":"High Risk Profile","groupKey":"safety-risk","groupName":"Safety/risk tags"},{"key":"sedation-risk","name":"Sedation Risk","groupKey":"safety-risk","groupName":"Safety/risk tags"},{"key":"liver-caution","name":"Liver Caution","groupKey":"safety-risk","groupName":"Safety/risk tags"},{"key":"pregnancy-caution","name":"Pregnancy Caution","groupKey":"safety-risk","groupName":"Safety/risk tags"},{"key":"medication-interaction-risk","name":"Medication Interaction Risk","groupKey":"safety-risk","groupName":"Safety/risk tags"},{"key":"legal-caution","name":"Legal Caution","groupKey":"safety-risk","groupName":"Safety/risk tags"},{"key":"pre-sleep-use","name":"Pre Sleep Use","groupKey":"usage-timing","groupName":"Usage/timing tags"}],"substanceType":"Synthetic prescription antidepressant","primaryDisplayName":"Agomelatine","canonicalIdentityName":"Agomelatine"},"warnings":[{"code":"profile_card","message":"Profile card content is incomplete.","severity":"info"}],"references":[{"id":"6eca88bd-3b6c-41c2-afce-06300e7bc901","doi":null,"url":"https://pubchem.ncbi.nlm.nih.gov/compound/82148","notes":"Chemical identity, CAS 138112-76-2, molecular formula C15H17NO2, PubChem CID 82148, and synonyms including Valdoxan, Thymanax, and S-20098.","pubmedId":null,"sourceType":"government_database","citationText":"PubChem. Agomelatine (CID 82148). Accessed 2026-10-19.","publishedDate":null},{"id":"0bc1c8cf-7370-4b44-934c-e55faf69d6d1","doi":null,"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/valdoxan","notes":"Current EU authorisation summary for adult major depression, prescription-only status, labelled tablets and treatment context, liver-test schedule, MT1/MT2 and 5-HT2C mechanism, mixed pivotal efficacy results, common adverse effects, and core restrictions.","pubmedId":null,"sourceType":"regulatory_review","citationText":"European Medicines Agency. Valdoxan EPAR overview, revision 27. Accessed 2026-10-19.","publishedDate":null},{"id":"8eef1a95-7468-4da0-91cc-3250983ac8a3","doi":null,"url":"https://www.ema.europa.eu/en/documents/product-information/valdoxan-epar-product-information_en.pdf","notes":"Current EU Summary of Product Characteristics and leaflet: adult indication, labelled dose context, liver monitoring and stopping rules, adverse-event frequencies, contraindications, CYP1A2 interactions, pregnancy/lactation precautions, age limits, peak plasma time and half-life.","pubmedId":null,"sourceType":"regulatory_label","citationText":"European Medicines Agency. Valdoxan: EPAR product information, revision 27. Updated 2025-04-15; accessed 2026-10-19.","publishedDate":"2025-04-14T22:00:00.000Z"},{"id":"770aa69e-5ab8-4c33-83ae-9965b04532f2","doi":null,"url":"https://www.gov.uk/drug-safety-update/agomelatine-valdoxan-risk-of-liver-toxicity","notes":"Safety update emphasizing baseline and follow-up liver function tests, 3x upper-limit transaminase stopping rule, liver-injury symptoms, and not recommended use in patients over 75 years.","pubmedId":null,"sourceType":"drug_safety_update","citationText":"Medicines and Healthcare products Regulatory Agency. Agomelatine (Valdoxan): risk of liver toxicity. GOV.UK Drug Safety Update. Published 2014-12-11.","publishedDate":"2014-12-10T23:00:00.000Z"},{"id":"f5035a54-81ee-4420-9caf-4987c4db608d","doi":"10.1016/S0140-6736(17)32802-7","url":"https://pubmed.ncbi.nlm.nih.gov/29477251/","notes":"Large network meta-analysis in adult major depressive disorder; all antidepressants were more efficacious than placebo, with agomelatine among treatments with favourable acceptability in the included evidence base.","pubmedId":"29477251","sourceType":"systematic_review_network_meta_analysis","citationText":"Cipriani A, et al. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder. Lancet. 2018;391(10128):1357-1366.","publishedDate":"2018-02-20T23:00:00.000Z"},{"id":"ec7eacba-9029-4685-8222-52b0923ada93","doi":"10.1517/14656566.2011.607812","url":"https://pubmed.ncbi.nlm.nih.gov/21916789/","notes":"Clinical review of agomelatine. Author, issue and pages corrected to the DOI/PMID bibliographic record; label is used for current safety details.","pubmedId":"21916789","sourceType":"clinical_review","citationText":"Carney RM, Shelton RC. Agomelatine for the treatment of major depressive disorder. Expert Opin Pharmacother. 2011;12(15):2411-2419.","publishedDate":"2011-09-30T22:00:00.000Z"},{"id":"49f8c166-b5ec-4508-a8fe-12e0d5b192df","doi":"10.1186/s40303-015-0011-7","url":"https://pubmed.ncbi.nlm.nih.gov/25932327/","notes":"Systematic review of trial, post-marketing, pharmacovigilance, and case-report evidence supporting clinically meaningful and dose-related liver-injury risk and continued liver-function monitoring.","pubmedId":"25932327","sourceType":"systematic_review","citationText":"Freiesleben SD, Furczyk K. A systematic review of agomelatine-induced liver injury. J Mol Psychiatry. 2015;3:4.","publishedDate":"2015-04-20T22:00:00.000Z"},{"id":"eadcb18b-1091-44fc-a343-50695620b4aa","doi":null,"url":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22agomelatine%22&limit=1","notes":"The generic-name search returned NOT_FOUND / No matches found on 2026-10-19; the matching prescription-label dataset search also returned no matches. Database absence is a scoped observation, not proof of global legal or import status.","pubmedId":null,"sourceType":"regulatory_database_check","citationText":"FDA openFDA Drugs@FDA generic-name search for agomelatine. Checked 2026-10-19.","publishedDate":"2026-10-18T22:00:00.000Z"},{"id":"74ad7a29-e3c1-4444-85a4-f59745312a7c","doi":null,"url":"https://www.fda.gov/drugs/development-approval-process-drugs/national-drug-code-database-background-information","notes":"FDA explains that inclusion of a firm or product in the NDC Directory does not denote FDA approval.","pubmedId":null,"sourceType":"regulatory_guidance","citationText":"U.S. Food and Drug Administration. National Drug Code Database Background Information. Accessed 2026-07-14.","publishedDate":null},{"id":"f6bf1cae-57e6-415e-a8c8-9f744e28d5e6","doi":null,"url":"https://api.nootropicsindex.com/api/supplements/by-slug/agomelatine/details","notes":"Current inspect inventory: 3 active offers / 6 total; active titles describe 25 mg tablets in different pack sizes while catalog form is capsules. Routine form-label follow-up; listing context supplies no medical or quality evidence.","pubmedId":null,"sourceType":"product_listing","citationText":"NootropicsIndex Agomelatine product inventory. Checked 2026-10-19.","publishedDate":null},{"id":"b998f2e5-314a-4be0-afd3-61d53f934511","doi":"10.1097/JCP.0b013e3181d420a7","url":"https://pubmed.ncbi.nlm.nih.gov/20520286/","notes":"Eight-week trial in 511 adults with major depressive disorder. Higher-dose arm improved the primary outcome versus placebo; lower-dose arm did not. Transient aminotransferase elevations occurred in 4.5% in the higher-dose arm. Not a healthy-user nootropic trial.","pubmedId":"20520286","sourceType":"randomized_controlled_trial","citationText":"Zajecka J, et al. Efficacy and safety of agomelatine in the treatment of major depressive disorder: a multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychopharmacol. 2010;30(2):135-144.","publishedDate":"2010-03-31T22:00:00.000Z"}],"riskRatings":[{"id":"0c861652-4d15-4a30-8e1d-f9ef1607e67b","key":"liver-kidney-caution","name":"Liver / kidney caution","note":"The regulator-required all-patient testing schedule and potentially severe attributable liver injury justify high rather than moderate at ordinary labelled oral use. Trial rates are population-specific and do not quantify healthy-user incidence.","riskScore":4,"confidence":"high","safetyNote":"Baseline and repeated liver-function testing are required; hepatic impairment and baseline transaminases above three times normal are contraindications, and rare serious hepatic outcomes are reported.","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","evidenceGrade":"A"},{"id":"56ba299a-0ade-477e-b688-66d0222bbd44","key":"interaction-risk","name":"Interaction risk","note":"Fluvoxamine increased agomelatine exposure about 60-fold in the EU label.","riskScore":4,"confidence":"high","safetyNote":"Potent CYP1A2 inhibitors such as fluvoxamine and ciprofloxacin are contraindicated; moderate inhibitors, smoking, rifampicin, alcohol, and hepatotoxic medicines require clinician review.","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","evidenceGrade":"A"},{"id":"d1fc40c8-1a29-4b07-b78c-427e51dca2b1","key":"legal-regulatory-risk","name":"Legal / regulatory risk","note":"EU prescription authorisation is current as checked 2026-10-19; an FDA generic-name dataset search returned no matches. 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EMA lists Valdoxan for major depressive episodes in adults and as prescription-only in the European Union.","tone":"warning","label":null,"title":"What Agomelatine is","value":null,"metadata":{},"blockType":"paragraph","sectionKey":"overview","referenceId":"0bc1c8cf-7370-4b44-934c-e55faf69d6d1","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"024cc663-81c9-4d59-b5a0-091b6003f95c","body":"Regulatory review and depression trials support a condition-specific medical use. 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This clinical population and treatment window cannot establish a same-day nootropic benefit.","tone":"neutral","label":null,"title":"Individual trials can be mixed","value":null,"metadata":{},"blockType":"paragraph","sectionKey":"overview","referenceId":"b998f2e5-314a-4be0-afd3-61d53f934511","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"0842deb9-c8f6-499b-9746-180adf8cc65b","body":"Agomelatine stimulates MT1 and MT2 receptors and blocks 5-HT2C receptors. EMA says this may increase dopamine and noradrenaline signalling and help normalise sleep patterns in depression; this is psychiatric-drug pharmacology, not a supplement mechanism.","tone":"neutral","label":"MT1/MT2 and 5-HT2C","title":"Melatonin receptors plus 5-HT2C blockade","value":"Circadian and mood pathways","metadata":{},"blockType":"mechanism","sectionKey":"mechanism","referenceId":"0bc1c8cf-7370-4b44-934c-e55faf69d6d1","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"e51578f3-338b-4b0f-aa76-9a26b0050c13","body":"The EU label describes 25 mg once daily at bedtime, with a possible prescriber-managed increase to 50 mg after two weeks without improvement and an individual benefit-risk review. These are prescription-label figures, not a consumer serving recommendation. The required liver-test schedule is detailed in Safety.","tone":"danger","label":"Prescriber-managed tablets","title":"EU prescription-label dosage context","value":"25-50 mg","metadata":{},"blockType":"dosage","sectionKey":"dosage","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"faf89133-89d2-485b-a317-e4e16ed82c60","body":"Peak plasma concentration and mean plasma half-life are each about 1-2 hours. Those pharmacokinetic figures do not establish an acute nootropic effect, a same-night clinical onset, or a therapeutic-effect duration; depression outcomes were assessed over weeks.","tone":"caution","label":null,"title":"Plasma timing is not effect duration","value":null,"metadata":{},"blockType":"timeline","sectionKey":"timeline","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"230a8609-d487-4ae6-a172-9065158b5d7e","body":"The EU label requires liver tests before treatment, around weeks 3, 6, 12 and 24, after dose increases, and later when clinically indicated. Treatment should not start, or should stop, when ALT or AST exceed three times the upper limit of normal.","tone":"danger","label":null,"title":"Liver monitoring is a condition of use","value":null,"metadata":{},"blockType":"side_effect","sectionKey":"safety","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"ceb4e5ac-5bcb-4a5b-94ca-c96cd8b7a675","body":"The EU label reports liver-enzyme elevations above three times normal in 1.2% at the lower labelled dose and 2.6% at the higher dose, versus 0.5% with placebo. These are trial-patient rates, not healthy-user incidence estimates. Rare hepatitis and hepatic failure, with exceptional fatal or transplant cases in patients with hepatic risk factors, establish potential severity. Most reported injury was reversible after discontinuation, but severe outcomes may not be. High rather than moderate reflects this attributable oral-dose hazard and mandatory testing for all patients; it does not rest on prescription status, interactions, pregnancy or overdose alone.","tone":"danger","label":null,"title":"Why the oral liver hazard warrants high risk","value":null,"metadata":{},"blockType":"side_effect","sectionKey":"safety","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"792f0b39-363d-4d70-b0b7-716215943a22","body":"The EU label says agomelatine should not be used at age 75 or older and is not recommended under 18. Prescribing also requires caution with bipolar disorder or mania and close monitoring for worsening depression, suicidal thoughts, or behavioural changes, especially early and after dose changes.","tone":"warning","label":null,"title":"Age, mania and suicidality cautions","value":null,"metadata":{},"blockType":"side_effect","sectionKey":"safety","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"6a8beec8-27a4-4c52-80c9-fbe72158a7f5","body":"Agomelatine is metabolised mainly by CYP1A2. Fluvoxamine and ciprofloxacin are contraindicated; moderate CYP1A2 inhibitors such as propranolol or enoxacin require caution, and rifampicin or heavy smoking may reduce exposure. Medication and smoking changes belong with the prescriber.","tone":"danger","label":null,"title":"CYP1A2 interactions are central","value":null,"metadata":{},"blockType":"interaction","sectionKey":"interactions","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"f46ec87a-0557-488c-a49c-3fd94d4d1322","body":"The EU label says combining agomelatine with alcohol is not advisable. Alcohol use disorder, substantial alcohol intake, obesity or fatty-liver disease, diabetes, and other potentially hepatotoxic medicines raise the need for careful benefit-risk review and surveillance.","tone":"warning","label":null,"title":"Alcohol and liver-risk stacking","value":null,"metadata":{},"blockType":"interaction","sectionKey":"interactions","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"bd93977e-fcff-4f2e-a1b0-a12e1d6ac16c","body":"Human pregnancy data are limited, and the EU label says it is preferable to avoid Valdoxan during pregnancy. During lactation, a clinician must weigh the benefit of treatment against breastfeeding because infant risk cannot be excluded.","tone":"warning","label":null,"title":"Pregnancy and breastfeeding need specialist review","value":null,"metadata":{},"blockType":"side_effect","sectionKey":"safety","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"c07ef39e-68c6-49d3-9b7f-2d8f37513803","body":"As of 19 October 2026, the EMA lists Valdoxan as a prescription-only medicine authorised in the European Union for major depressive episodes in adults. EU authorisation does not establish U.S. approval or lawful import in any other jurisdiction.","tone":"danger","label":null,"title":"EU prescription medicine; other markets vary","value":null,"metadata":{"asOfDate":"2026-10-19"},"blockType":"legal_status","sectionKey":"legal-status","referenceId":"0bc1c8cf-7370-4b44-934c-e55faf69d6d1","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"cf89738c-5b6d-494e-a44e-bb50233f483c","body":"On 19 October 2026, an FDA openFDA Drugs@FDA generic-name search for agomelatine returned no matches; the corresponding label dataset search also returned no matches. This is a dated database observation, not a comprehensive legal determination or evidence that an online listing can lawfully be imported.","tone":"caution","label":null,"title":"U.S. database check is not an import ruling","value":null,"metadata":{"asOfDate":"2026-10-19"},"blockType":"legal_status","sectionKey":"legal-status","referenceId":"eadcb18b-1091-44fc-a343-50695620b4aa","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"01c6220c-3cce-49e4-b162-cdc4e8928bff","body":"For Agomelatine, Valdoxan, Thymanax or Agoprex listings, check the stated active ingredient, tablet strength, pack size, manufacturer, dispensing route and prescription requirements in the relevant jurisdiction. Product availability alone does not establish approval, quality or individual suitability.","tone":"warning","label":null,"title":"Compare identity and access route before price","value":null,"metadata":{},"blockType":"buying_note","sectionKey":"buying","referenceId":"f6bf1cae-57e6-415e-a8c8-9f744e28d5e6","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"9afb536d-f1c9-4290-9a3a-12a0d2a125b4","body":"Compare the same stated tablet strength and number of units before comparing pack prices. Current product titles describe tablets while the catalog form filter says capsules, so confirm the actual dosage form on the merchant page. A loose-powder listing is not equivalent to the labelled finished tablet; price per gram alone cannot establish equivalence or quality.","tone":"caution","label":null,"title":"Compare finished-tablet strength and pack size","value":null,"metadata":{},"blockType":"buying_note","sectionKey":"buying","referenceId":"f6bf1cae-57e6-415e-a8c8-9f744e28d5e6","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"c2a0a205-bf6a-44bc-9055-a475193ff291","body":"Not in the supplement sense. It is a prescription antidepressant where authorised, and its depression and sleep-pattern evidence does not establish memory, focus, or productivity benefits in healthy users.","tone":"warning","label":null,"title":"Is Agomelatine a nootropic?","value":null,"metadata":{},"blockType":"faq","sectionKey":"faq","referenceId":"f5035a54-81ee-4420-9caf-4987c4db608d","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"39e9f13c-6715-4d58-a49f-d11b97ee2602","body":"The dosage section gives the EU prescription-label range. It is not an established healthy-user nootropic dose; label use includes prescriber assessment and liver testing rather than a self-directed supplement serving.","tone":"warning","label":null,"title":"What is the Agomelatine dose?","value":null,"metadata":{},"blockType":"faq","sectionKey":"faq","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"035d67dd-70fe-43b4-afa3-ab8d8e27625c","body":"Plasma peak and half-life describe drug concentration, not the duration of a cognitive or antidepressant effect. Clinical outcomes were measured over weeks; a reliable single-dose nootropic duration or evidence-based consumer cycle is not established.","tone":"caution","label":null,"title":"What do duration and cycling claims mean?","value":null,"metadata":{},"blockType":"faq","sectionKey":"faq","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"5de398b3-01ad-45f4-a644-36e4c6a948d5","body":"No. The rating describes the potential severity of an established oral liver hazard and its required monitoring, rather than claiming severe harm in most users. Healthy-user nootropic safety is not established, and depression-trial adverse-event rates should not be presented as healthy-user incidence.","tone":"danger","label":null,"title":"Does high risk mean serious injury is common?","value":null,"metadata":{},"blockType":"faq","sectionKey":"faq","referenceId":"8eef1a95-7468-4da0-91cc-3250983ac8a3","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null},{"id":"a4c19293-7a4c-4d25-8910-384c08878502","body":"This profile separates regulated depression-treatment evidence from nootropic marketing. Product listings inform identity and pack context only; they do not establish efficacy, approval, lawful import, or medical suitability.","tone":"caution","label":null,"title":"Evidence boundary","value":null,"metadata":{},"blockType":"callout","sectionKey":"overview","referenceId":"0bc1c8cf-7370-4b44-934c-e55faf69d6d1","relatedProfile":null,"relatedProfileId":null,"relatedProfileName":null}],"effectRatings":[{"id":"601cade2-4412-49a2-8400-ce17ebd817ce","key":"mood-wellbeing","name":"Mood / wellbeing","note":"Regulatory approval and meta-analysis support an antidepressant effect, while EMA describes mixed individual trials and potentially lower benefit than some alternatives.","confidence":"high","referenceId":"f5035a54-81ee-4420-9caf-4987c4db608d","timeProfile":"chronic","claimWording":"Adult depression trials show an antidepressant effect on average; these findings do not establish healthy-user mood enhancement.","evidenceGrade":"B","magnitudeScore":3},{"id":"3984a50c-20e2-42fa-805f-221aefde2b49","key":"sleep-quality","name":"Sleep quality","note":"Keep the effect within the authorised depression context.","confidence":"medium","referenceId":"0bc1c8cf-7370-4b44-934c-e55faf69d6d1","timeProfile":"chronic","claimWording":"Sleep-pattern outcomes have been studied in adults with depression; this does not establish use as a standalone sleep supplement.","evidenceGrade":"B","magnitudeScore":2},{"id":"52263608-4f90-408a-8e52-0b89174c863f","key":"focus-attention","name":"Focus / attention","note":"This explicitly corrects the unsupported claims on the legacy page.","confidence":"medium","referenceId":"f5035a54-81ee-4420-9caf-4987c4db608d","timeProfile":"unknown","claimWording":"No reliable human evidence establishes a focus, concentration, or productivity benefit in healthy users.","evidenceGrade":"D","magnitudeScore":0}],"schemaVersion":2,"structuredAliases":[]},"source_profile_updated_at":"2026-10-19T19:35:25.464Z","published_at":"2026-10-19T19:35:30.345Z","updated_at":"2026-10-19T19:35:30.345Z","form_family":{"familyKind":"form","role":"standalone","parent":null,"children":[],"siblings":[]}}}