title: Mazindol in narcolepsy and idiopathic and symptomatic hypersomnia refractory to stimulants: a long-term chart review.
abstract: OBJECTIVE
  Mazindol is a tricyclic, anorectic, non-amphetamine stimulant used in narcolepsy and obesity since 1970. This study aimed to evaluate the long-term benefit/risk ratio in drug-resistant hypersomniacs and cataplexy sufferers.
  
  
  METHODS
  By retrospective analysis of the patients' files in the hospitals of Paris-Salpêtrière (n=91), Montpellier (n=40) and Lyon (n=8), the benefit (Epworth Sleepiness Score (ESS), cataplexy frequency, authorization renewal) and tolerance (side-effects, vital signs, electrocardiogram and cardiac echography) of mazindol were assessed.
  
  
  RESULTS
  The 139 patients (45% men) aged 36±15years (range: 9-74) suffered narcolepsy (n=94, 66% with cataplexy), idiopathic (n=37) and symptomatic hypersomnia (n=8) refractory to modafinil, methylphenidate and sodium oxybate. Under mazindol (3.4±1.3mg/day, 1-6mg) for an average of 30months, the ESS decreased from 17.7±3.5 to 12.8±5.1, with an average fall of -4.6±4.7 (p<0.0001) and the frequency of cataplexy fell from 4.6±3.1 to 2±2.8 episodes per week. The cataplexy was eliminated in 14.5% of patients, improved in 27.5%, and unchanged in 29% (missing data in 29%). The treatment was maintained long term in 83 (60%) patients, and stopped because of a lack of efficacy (22%) and/or secondary effects (9%). There was no pulmonary hypertension in the 45 patients who underwent a cardiac echography. The most common adverse effects were dry mouth (13%), palpitations (10%, including one with ventricular hyperexcitability), anorexia (6%), nervousness (6%) and headaches (6%).
  
  
  CONCLUSIONS
  Mazindol has a long-term, favorable benefit/risk ratio in 60% of drug-resistant hypersomniacs, including a clear benefit on cataplexy.
authors.affiliation: National Reference Centre for Narcolepsy and Idiopathic Hypersomnia, France.
authors.forename: Nandini
authors.initials: N
authors.lastname: Nittur
authors.forename: Eric
authors.initials: E
authors.lastname: Konofal
authors.forename: Yves
authors.initials: Y
authors.lastname: Dauvilliers
authors.forename: Patricia
authors.initials: P
authors.lastname: Franco
authors.forename: Smaranda
authors.initials: S
authors.lastname: Leu-Semenescu
authors.forename: Valérie Cochen De
authors.initials: VC
authors.lastname: Cock
authors.forename: Clara O
authors.initials: CO
authors.lastname: Inocente
authors.forename: Sophie
authors.initials: S
authors.lastname: Bayard
authors.forename: Sabine
authors.initials: S
authors.lastname: Scholtz
authors.forename: Michel
authors.initials: M
authors.lastname: Lecendreux
authors.forename: Isabelle
authors.initials: I
authors.lastname: Arnulf
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D002385:Cataplexy / Q000188:drug therapy; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D020177:Idiopathic Hypersomnia / Q000188:drug therapy*; D008297:Male; D008454:Mazindol / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009290:Narcolepsy / Q000188:drug therapy*; D012189:Retrospective Studies; D014851:Wakefulness / Q000187:drug effects; D055815:Young Adult
chemical_list: D000697:Central Nervous System Stimulants; D008454:Mazindol