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%).

CONCLUSION:

Mazindol has a long-term, favorable benefit/risk ratio in 60% of drug-resistant hypersomniacs, including a clear benefit on cataplexy.

• Authors: Nandini Nittur, Eric Konofal, Yves Dauvilliers, Patricia Franco, Smaranda Leu-Semenescu, Valérie Cochen De Cock, Clara O Inocente, Sophie Bayard, Sabine Scholtz, Michel Lecendreux, Isabelle Arnulf
• Journal: Sleep medicine (Sleep Med) Vol. 14 Issue 1 Pg. 30-6 (Jan 2013) ISSN: 1878-5506 [Electronic] Netherlands
• PMID: 23036267 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 Elsevier B.V. All rights reserved.

Chemical References

• Central Nervous System Stimulants
• Mazindol

Topics

• Adolescent
• Adult
• Aged
• Blood Pressure (drug effects)
• Cataplexy (drug therapy)
• Central Nervous System Stimulants (adverse effects, therapeutic use)
• Child
• Female
• Heart Rate (drug effects)
• Humans
• Idiopathic Hypersomnia (drug therapy)
• Male
• Mazindol (adverse effects, therapeutic use)
• Middle Aged
• Narcolepsy (drug therapy)
• Retrospective Studies
• Wakefulness (drug effects)
• Young Adult