{"id":"93248c63-315d-53d6-bbb5-a76221c6b4da","stable_key":"6660bba2-4fa0-590a-bf52-9803a24bea9f:longterm-sleepiness","predicate":"decreases_in_recorded_experiment","statement":"Forty-week open-label narcolepsy extensions reported sustained benefit without observed tolerance during that period, with completer selection and later attrition.","claim_class":"observational","status":"source_recorded","evidence_grade":"ungraded","direction":"negative","is_public":true,"mechanism_event_id":"18086c24-efef-58d1-8fcf-2d044a8d970e","mechanism_event_label":"Forty-week open-label narcolepsy extensions reported sustained benefit without observed tolerance during that period, with completer selection and later attrition.","subject":{"id":"624e6a4b-f96d-5d12-8206-30d1e1715c26","slug":"modafinil","display_name":"Modafinil","entity_type_key":"drug"},"object":{"id":"1ea68d85-d35f-5609-bfa2-1f73e1e422eb","slug":"human-narcolepsy-sleepiness","display_name":"Human narcolepsy-associated excessive sleepiness","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"18086c24-efef-58d1-8fcf-2d044a8d970e","stable_key":"6660bba2-4fa0-590a-bf52-9803a24bea9f:longterm-sleepiness-event","event_type":"experimental_observation","label":"Forty-week open-label narcolepsy extensions reported sustained benefit without observed tolerance during that period, with completer selection and later attrition.","description":"Reinforcement, tolerance and withdrawal are different endpoints. Forty-week open-label narcolepsy extensions reported sustained benefit without evidence of tolerance during that period, but enrolled completers of prior trials and had subsequent attrition. They cannot demonstrate that tolerance never occurs over years or that all exposure patterns have the same discontinuation effects. [Long-term extension studies](https://pubmed.ncbi.nlm.nih.gov/10828434/)","status":"provisional","compartment":null,"participants":[{"entity":{"id":"624e6a4b-f96d-5d12-8206-30d1e1715c26","slug":"modafinil","display_name":"Modafinil","entity_type_key":"drug"},"role":"tested factor","stoichiometry":null,"state_label":"Continued modafinil in trial completers","sequence_order":0,"notes":""},{"entity":{"id":"1ea68d85-d35f-5609-bfa2-1f73e1e422eb","slug":"human-narcolepsy-sleepiness","display_name":"Human narcolepsy-associated excessive sleepiness","entity_type_key":"cellular_process"},"role":"measured outcome","stoichiometry":null,"state_label":"decrease","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_access","value_text":"Primary indexed abstract checked; full methods and figures not comprehensively reviewed.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_contrast","value_text":"{\"intervention\": \"Continued modafinil in trial completers\", \"comparator\": \"Within-study baseline/follow-up\", \"endpoint\": \"Forty-week open-label narcolepsy extensions reported sustained benefit without observed tolerance during that period, with completer selection and later attrition.\", \"effect_direction\": \"decrease\", \"combination\": \"single\", \"conditions\": []}","comparator":null,"unit":null,"notes":"Explicit extracted experimental comparison; source-derived draft.","entity":null},{"dimension":"experimental_model","value_text":"Human open-label extension studies, forty weeks; no proof that tolerance never occurs.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"interpretation_status","value_text":"Source-derived extraction of a fact-checked reference; access is explicit, not independent raw-data verification.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Interpret only within the recorded preparation, exposure and comparator. The complete source passage retains qualifications; unspecified doses/timing have not been extracted here. No clinical efficacy, nutrient deficiency or unique molecular mediation is inferred.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"Forty-week open-label narcolepsy extensions reported sustained benefit without observed tolerance during that period, with completer selection and later attrition.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"Long-term efficacy and safety of modafinil (PROVIGIL((R))) for the treatment of excessive daytime sleepiness associated with narcolepsy. | 2000 | DOI 10.1016/s1389-9457(00)00031-9 | PMID 10828434 | https://pubmed.ncbi.nlm.nih.gov/10828434/","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"source_locator","value_text":"Reviewed reference lines 164-164; exact primary location described in quoted passage where extracted.","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"72614e57-9b0a-5c7b-afdb-7e8bb80629b4","evidence_kind":"source_excerpt","locator":"Lines 164-164","start_line":164,"end_line":164,"excerpt":"Reinforcement, tolerance and withdrawal are different endpoints. Forty-week open-label narcolepsy extensions reported sustained benefit without evidence of tolerance during that period, but enrolled completers of prior trials and had subsequent attrition. They cannot demonstrate that tolerance never occurs over years or that all exposure patterns have the same discontinuation effects. [Long-term extension studies](https://pubmed.ncbi.nlm.nih.gov/10828434/)","model_system":"Human open-label extension studies, forty weeks; no proof that tolerance never occurs.","directness":"reported_statement","verification_status":"source_recorded","notes":"Exact excerpt of the retained AI-assisted reviewed reference; primary sources are cited in primary_references and access scope is retained. 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