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British Medical Journal (Clinical... Apr 1985Twenty patients with the narcoleptic syndrome were treated separately with dexamphetamine sulphate tablets 10 and 30 mg, Dexedrine Spansules 10 mg, mazindol 4 mg, and... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
Twenty patients with the narcoleptic syndrome were treated separately with dexamphetamine sulphate tablets 10 and 30 mg, Dexedrine Spansules 10 mg, mazindol 4 mg, and fencamfamin hydrochloride 60 mg daily. Each drug was given for four weeks and the effects compared. In these dosages the reported frequency of attacks of narcolepsy was roughly halved with each treatment, dexamphetamine 30 mg daily being only slightly more potent than 10 mg. The subjective effects of Dexedrine tablets and Spansules could not be distinguished by most patients. Effects on mood, alertness, and sympathomimetic side effects were largely inseparable with all these drugs, but a decrease in appetite was not reported by patients with narcolepsy.
Topics: Adult; Aged; Amphetamines; Central Nervous System Stimulants; Female; Humans; Indoles; Male; Mazindol; Middle Aged; Narcolepsy; Norbornanes
PubMed: 2859077
DOI: 10.1136/bmj.290.6476.1167 -
Sleep Medicine Clinics Sep 2019Idiopathic hypersomnia (IH) is characterized by excessive daytime sleepiness despite normal or prolonged sleep. IH is distinguished from narcolepsy by the female... (Review)
Review
Idiopathic hypersomnia (IH) is characterized by excessive daytime sleepiness despite normal or prolonged sleep. IH is distinguished from narcolepsy by the female predominance, severe morning inertia, continuous drowsiness (rather than sleep attacks), unrefreshing naps, absence of cataplexy, sleep onset in REM periods, and hypocretin deficiency. In IH, the multiple sleep latency test demonstrates low sensitivity, specificity, and reproducibility, compared with prolonged sleep monitoring. In some IH cases, an endogenous hypnotic peptide stimulating GABA receptors during wakefulness is suspected, which are improved by anti-GABA drugs. The benefits of modafinil, sodium oxybate, mazindol, and pitolisant were found in mostly retrospective studies.
Topics: Central Nervous System Stimulants; Clarithromycin; Flumazenil; GABA Modulators; Humans; Idiopathic Hypersomnia; Mazindol; Modafinil; Orexins; Piperidines; Polysomnography; Precision Medicine; Sleep; Sodium Oxybate; Wakefulness; Wakefulness-Promoting Agents
PubMed: 31375202
DOI: 10.1016/j.jsmc.2019.05.007 -
Drug and Alcohol Dependence Oct 1995This double-blind placebo-controlled treatment study tested the efficacy of mazindol in currently cocaine-dependent out-patients. Forty-three patients were randomized to... (Clinical Trial)
Clinical Trial Randomized Controlled Trial
This double-blind placebo-controlled treatment study tested the efficacy of mazindol in currently cocaine-dependent out-patients. Forty-three patients were randomized to mazindol (2 mg QD) vs. placebo treatment for 6 weeks. All patients received weekly group counseling. Patients improved with respect to objective (urine toxicology) and subjective (self-report of times used, dollars spent, craving, etc.) measures. There was no response difference between patients treated with mazindol and those who received placebo.
Topics: Adult; Central Nervous System Stimulants; Cocaine; Double-Blind Method; Female; Humans; Male; Mazindol; Neurologic Examination; Substance Abuse Detection; Substance Withdrawal Syndrome; Substance-Related Disorders
PubMed: 8556974
DOI: 10.1016/0376-8716(95)01174-4 -
The American Journal of Drug and... Nov 1995We conducted a double-blind, randomized clinical trial of mazindol (n = 37) for the prevention of relapse to cocaine abuse in methadone-maintained patients who were in... (Clinical Trial)
Clinical Trial Randomized Controlled Trial
We conducted a double-blind, randomized clinical trial of mazindol (n = 37) for the prevention of relapse to cocaine abuse in methadone-maintained patients who were in the "action" stage of change, i.e., had a history of cocaine dependence but who had been abstinent for at least 2 weeks prior to entry into the study. Eight-one percent of subjects completed the 12-week course of treatment. Overall, cocaine use during the study was comparatively low-17% of the urine screens submitted were positive for cocaine metabolite. Differences between the mazindol and placebo groups of rates of relapse, number of days to relapse, and cocaine use did not reach statistical significance, but were in the direction of a treatment effect. Results suggest that stage of abstinence initiation may be a potentially useful category to employ as an independent variable in future pharmacotherapy trials for the treatment of cocaine addiction in this patient population.
Topics: Adult; Cocaine; Combined Modality Therapy; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Mazindol; Methadone; Narcotic Antagonists; Psychotherapy; Recurrence; Substance-Related Disorders
PubMed: 8561098
DOI: 10.3109/00952999509002711 -
American Journal of Medical Genetics Aug 1987
Clinical Trial
Topics: Child; Clinical Trials as Topic; Double-Blind Method; Growth Hormone; Humans; Indoles; Male; Mazindol; Muscular Dystrophies
PubMed: 3321999
DOI: 10.1002/ajmg.1320270433 -
Sleep 1984
Topics: Female; Humans; Indoles; Male; Mazindol; Narcolepsy
PubMed: 6484432
DOI: 10.1093/sleep/7.3.274 -
European Journal of Clinical... Aug 2016There are no pharmacokinetics studies in oral fluid reported in the literature, as well as there are no data on correlation of drug levels in plasma, urine, and oral... (Clinical Trial)
Clinical Trial
PURPOSE
There are no pharmacokinetics studies in oral fluid reported in the literature, as well as there are no data on correlation of drug levels in plasma, urine, and oral fluid in order to propose alternative matrices to monitor the use of mazindol by drivers. The present work aimed to study, preliminarily, mazindol's pharmacokinetics in plasma and oral fluid, as well as investigate the correlation of drug levels in urine, plasma, and oral fluid.
METHOD
Blood, urine, and oral fluid samples from seven healthy male volunteers were collected at 0, 1, 2, 4, 5, 6, 8, 10, and 24 h after administration of tablets of 2 mg mazindol and analyzed by a previously validated method by LC-MS with liquid-liquid extraction. Levels of the drug found were higher in plasma when compared with oral fluid and higher in urine in relation to plasma. The study of the mazindol's pharmacokinetics showed that the most suitable model to describe the variation of the concentration over time is the compartment open model with absorption and elimination following the first-order kinetics, and confirming literature data, drug is metabolized, being the major metabolite detected, but not quantified.
CONCLUSION
It was not found a good correlation between the concentrations of mazindol in urine and plasma, but between plasma and oral fluid, there was a good correlation, suggesting this as an alternative matrix to plasma. However, studies involving more subjects are needed.
Topics: Administration, Oral; Adult; Central Nervous System Stimulants; Healthy Volunteers; Humans; Male; Mazindol; Models, Biological; Saliva; Young Adult
PubMed: 27066959
DOI: 10.1007/s00228-016-2055-8 -
Sleep Medicine Jan 2013Mazindol 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... (Clinical Trial)
Clinical Trial
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.
Topics: Adolescent; Adult; Aged; Blood Pressure; Cataplexy; Central Nervous System Stimulants; Child; Female; Heart Rate; Humans; Idiopathic Hypersomnia; Male; Mazindol; Middle Aged; Narcolepsy; Retrospective Studies; Wakefulness; Young Adult
PubMed: 23036267
DOI: 10.1016/j.sleep.2012.07.008 -
Sleep 1986Mazindol, a new anorexiant, was administered at a daily dose of 0.5-4 mg to 10 narcoleptic subjects aged 21-63 years. All the patients suffered from sleep attacks and...
Mazindol, a new anorexiant, was administered at a daily dose of 0.5-4 mg to 10 narcoleptic subjects aged 21-63 years. All the patients suffered from sleep attacks and one or more of the REM-related symptoms. Eight patients received only mazindol, and two patients received mazindol simultaneously with clomipramine or flurazepam. Sleep attacks were reduced in nine patients, and cataplexy was also markedly reduced in four patients. Mild adverse reactions were reported in six patients: two patients complained of headache, four of nocturnal sleep disturbance, and two of reduced appetite. Most side effects disappeared spontaneously or after dose reduction, and none of the patients had to stop medication. The results suggest that mazindol is effective not only for sleep attacks but also for cataplexy. It is recommended as a treatment for mild cases of narcolepsy.
Topics: Adult; Cataplexy; Female; Humans; Indoles; Male; Mazindol; Middle Aged; Narcolepsy
PubMed: 3704452
DOI: 10.1093/sleep/9.1.265 -
Lancet (London, England) Jan 1988
Clinical Trial
Topics: Child; Clinical Trials as Topic; Heart Rate; Humans; Indoles; Male; Mazindol; Muscular Dystrophies
PubMed: 2893022
DOI: 10.1016/s0140-6736(88)92759-6