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Abstract
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Study Objectives: To ascertain complications associated with high-dose stimulant therapy in patients with narcolepsy or idiopathic hypersomnia.
DESIGN: Case-control, retrospective chart review. Setting: Sleep center in an academic hospital. Patients: 116 patients with narcolepsy or idiopathic hypersomnia were individually matched by sex, diagnosis, age of onset, and duration of follow-up from both onset and diagnosis. Members of the high-dose group (n = 58) had received at least 1 stimulant at a dosage ≥ 120% of the maximum recommended by the American Academy of Sleep Medicine Standards of Practice Committee. The standard-dose control group (n = 58) had received stimulants at a dosage ≤ 100% of the American Academy of Sleep Medicine guidelines. Interventions: N/A. Measurements and Results: The prevalence of psychosis (odds ratio = 12.0 [1.6-92.0]), alcohol or polysubstance misuse (odds ratio = 4.3 [1.2-15.2]), and psychiatric hospitalization (odds ratio = 3.2 [1.1-10.0]) was significantly increased in the high-dose group. More high-dose patients also experienced tachyarrhythmias (odds ratio = 3.3 [0.92-12.1] and anorexia or weight loss (odds ratio = 11.0 [1.4-85.2]). The frequency of physician-diagnosed depression, drug-seeking and suicide-related behaviors, hypertension, and cardiovascular disease did not differ significantly between the groups.
CONCLUSIONS: This study demonstrated a significantly higher occurrence of psychosis, substance misuse, and psychiatric hospitalizations in patients using high-dose stimulants compared to those using standard doses. Tachyarrhythmias and anorexia or weight loss were also more common in this group as compared with controls. Clinicians should be very cautious in prescribing dosages that exceed maximum guidelines.; Indications:113 patients with idiopathic hypersomnia or narcolepsy, with or without cataplexy.; Patients:116 in-/outpatients. High dose group: n=58, 31 men and 27 women, mean age at onset was 18.9 years, who all received Ritalin. Standard dose group: n=58, 31 men and 27 women, mean age at onset was 18.0 years, of whom 55 received Ritalin. 1 dropout due to side effects.; TypeofStudy:The risks of high-dose stimulants (including Ritalin) in the treatment of narcolepsy or idiopathic hypersomnia were evaluated in this study. Retrospective, open, comparative, controlled study.; DosageDuration:Median standard dose was 60 mg (5-100) given for a mean duration of 11.7 years. Median high dose was 195 mg (100-1400 mg) given for a mean duration of 14.7 years.; ComparativeDrug:Standard doses for methamphetamine, dextroamphetamine, pemoline and amphetamine were 27 mg (10-80), 30 mg (15-70), 56 mg (37-90) and 25 mg (10-40). Mean duration of treatment for the above drugs were 18.4, 15.8, 6.2 and 0.01 years, respectively. High doses for methamphetamine, dextroamphetamine, pemoline, amphetamine, amphetamine/dextroamphetamine were 60 mg (15-225), 40 mg (20-375), 127 mg (56-300), 20 mg and 60 mg (50-160). Mean duration of treatment for the above drugs were 7.2, 3.2, 3.3, 2.0 and 2.3 years, respectively; Results:Ritalin was the most commonly prescribed drug in both the high and standard dose group (100 and 95%, respectively) while methamphetamine was second (55% and 21%, respectively). Patients in the high dose group showed an increased frequency of psychosis (odds ratio = 12.0 [1.6-92.3]), substance misuse (odds ratio = 4.3 [1.2-15.2]), and psychiatric hospitalization (odds ratio = 3.2 [1.1-10.0]). Drug-seeking behavior, suicide, attempted suicide, or suicidal ideation (odds ratio = 5.0 [0.6-42.8]) also occurred more frequently in the high-dose group, but was not statistically significant. 14 patients developed psychoses in the high-dose group. Complications occurred in 6 patients using Ritalin at a median dosage of 170 mg (range 120-500 mg). Symptoms disappeared on reduction of the dose to a median of 80 mg (range 15-260 mg). In 1 patient, symptoms emerged at a dosage of 80 mg of methamphetamine, continued after substitution of 120 mg of Ritalin, and later disappeared after discontinuation of all stimulants. In the low dose group, 3 developed psychoses; all were receiving Ritalin at a median dose of 60 mg (range 30-80 mg). The frequency of hypertension (odds ratio = 1.1 [0.5-2.4]) and cardiovascular disease (odds ratio = 1.0 [0.3-3.1]) did not differ substantially between the groups. Significantly more patients in the high-dose group experienced anorexia or weight loss (odds ratio = 11.0 [1.4-85.2]). The odds of developing tachyarrhythmias were 3.3 times higher (95% confidence interval: 0.92-12.1) in patients in the high-dose than in the standard-dose group. In the high-dose group, a direct association between stimulant medications and tachyarrhythmias was indeterminate in 9/11 patients (82%), due to a combination of persistent use of the medication at an unaltered or increased dosage, incomplete medical records, or concomitant medical therapy for the arrhythmia.; AdverseEffects:6 patients developed psychoses while on high dose Ritalin, 3 while on standard dose Ritalin. 1 dropped out. Hypertension, cardiovascular disease, tachyarrhythmias, anorexia or weight loss, alcohol/substance abuse, depression, suicide, attempted suicide, or suicidal ideation and drug-seeking behavior also occurred in unspecified number of patients.; AuthorsConclusions:This study demonstrated a significantly higher occurrence of psychosis, substance misuse, and psychiatric hospitalizations in patients using high-dose stimulants compared to those using standard doses. Tachyarrhythmias and anorexia or weight loss were also more common in this group as compared with controls. Clinicians should be cautious in prescribing dosages that exceed maximum guidelines.; FreeText:All patients treated between 1950 and 2000 for narcolepsy or idiopathic hypersomnia were identified. Patients in the high-dose group received at least 1 stimulant at a dosage greater than or equal to 120% of the maximum recommended by the American Academy of Sleep Medicine Standards of Practice Committee. Control subjects received stimulants at a dosage less than or equal to 100% of the maximum recommended by the American Academy of Sleep Medicine. The patients' records were reviewed and analyzed for diagnoses of psychosis, depression, hypertension, cardiovascular disease, tachyarrhythmias, alcohol or other substance misuse, drug-seeking and suicide-related behaviors, psychiatric hospitalization, and anorexia or weight loss. Concomitant drug: stimulant agent, antiarrhythmic agent. Tests: BP, body weight.
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