Bupropion as a Possible Treatment Option for Restless Legs ...

Bupropion as a Possible Treatment Option for Restless Legs
Syndrome
Jennifer J Lee, Joseph Erdos, Meghan F Wilkosz, Renee LaPlante, and Brenda Wagoner
Restless legs syndrome (RLS) is a
common movement disorder that
affects an estimated 2–15% of the population.
1 Epidemiologic data indicate that
the prevalence of RLS is greater in
women and increases with age. 1,2 People
with this disorder frequently report an irresistible
urge to move their legs and unpleasant
sensations that worsen during
periods of rest, often interfering with
sleep. 1 Because RLS can lead to significantly
decreased quality of life, patients
often present with sleep disturbance as
their primary reason for seeking medical
attention. 2,3 Unfortunately, many cases of
RLS are unrecognized or misdiagnosed
as insomnia, anxiety, or depression,
thus leading to inadequate treatment of
RLS. 2,4-6
Establishing an accurate diagnosis is
critical. Given the lack of laboratory data
and physical exam findings to diagnose
RLS, clinical history and subjective
complaints from the patient and his/her
bed partner guide the diagnosis. 3,7,8 Conditions
known to mimic RLS, including leg cramps, peripheral
neuropathy, varicose veins, intermittent claudication,
positional discomfort, neuroleptic-induced akathesia,
and arthritis should be ruled out. 1,3 Identification of secondary
causes of RLS, such as iron deficiency, end-stage
renal disease, diabetes mellitus, pregnancy, and medications,
should be considered and treated accordingly. 1,2,5-7
We report a case of RLS successfully managed with
bupropion XL (Wellbutrin XL).
Author information provided at the end of the text.
OBJECTIVE: To describe a case of restless legs syndrome (RLS) successfully
managed with bupropion.
CASE SUMMARY: A 45-year-old female presented to a Veterans Affairs primary
care clinic with a history of chronic insomnia. Her complicated history of treatment
failure to sedative–hypnotic agents, continued sleep disturbances, and complaints
of intolerable leg sensations fostered collaboration between a psychiatrist
and pharmacist to identify effective treatment. Further review of her medical history
and subjective complaints led to a diagnosis of RLS. Based on this new diagnosis,
she was prescribed several Food and Drug Administration–approved and alternative
agents recommended for the management of RLS. Unfortunately, each medication
resulted in a variety of intolerable adverse effects, limiting the list of treatment
options. Although not widely used for RLS, bupropion XL (Wellbutrin XL) 150 mg
daily was initiated, resulting in resolution of RLS within 3 days.
DISCUSSION: RLS can be an extremely disabling disorder and affects many
people. For most patients, dopamine agonists are the treatment of choice for
symptomatic relief. However, for patients unable to tolerate this drug class, small
trials and case reports have identified alternative agents. This case supports
findings from other cases suggesting a beneficial response with bupropion for the
management of RLS.
CONCLUSION: Bupropion may be a treatment option for patients who have RLS
and are unable to tolerate dopamine agonists.
KEY WORDS: bupropion, restless legs syndrome.
Ann Pharmacother 2009;43:370-4.
Published Online, 3 Feb 2009, www.theannals.com, DOI 10.1345/aph.1L035
Case Report
The psychiatry and pharmacy services at a Veterans Affairs
(VA) clinic collaborated in the case of a 45-year-old
female with a longstanding history of insomnia (Table 1).
In brief, the patient’s history was significant for Tourettelike
symptoms during childhood, including akathisia, head
jerking, and hitting her legs. These tics resolved on their
own when she enrolled in the National Guard at the age of
19 years. The patient later transferred to active duty in the
Army, where she experienced initial episodes of difficulty
sleeping. After discharge from the Army, she reported continued
sleep disturbances and was diagnosed with insom-
370 ■ The Annals of Pharmacotherapy ■ 2009 February, Volume 43 www.theannals.com

nia. In her 20s, she reported new complaints of uncomfortable
leg sensations and an inability to sit for long periods of
time. These symptoms worsened during pregnancy and
continued into her 30s and 40s. Subsequently, she experienced
episodes of crying, feelings of worthlessness, sleep
disturbances, difficulty coping, and isolation. The patient
was diagnosed by her private physician and psychiatrist
with depression and bipolar II disorder. Over the course of
several years, she was treated with antidepressants (escitalopram,
trazodone), sedative–hypnotics (zolpidem, temazepam,
alprazolam), mood stabilizers (divalproex, oxcarbazepine,
lamotrigine), and antipsychotics (quetiapine).
The patient continued to have sleep difficulties, which ultimately
led to a suicide attempt. A sleep study was conducted
and care was transferred to the VA shortly afterwards.
During her initial visit to the VA clinic, the patient reported
recurrent sleep disturbances, difficulty falling
asleep, and restlessness during sleep. She reported good
sleep hygiene but her “body won’t stop moving” and her
“legs were on fire.” Given her complicated sleep history, a
psychiatrist collaborated with the pharmacy service to prescribe
alternative sedative–hypnotics for sleep. As her
symptoms and sleep history were further explored, a trial
of zaleplon 10 mg at bedtime was initiated. During her
subsequent visits, she reported slight improvement in sleep
but described “creepy crawling” sensations in her legs and
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Table 1. Patient Characteristics
Age, y 45
Sex female
Race white
Past medical history asthma
hypothyroidism
depression
chronic insomnia
bipolar II disorder
Past surgical history total abdominal hysterectomy with
unilateral oophrectomy
tonsillectomy
septoplasty
bunion removal
Medications trazodone 150 mg at bedtime
lamotrigine 25 mg twice daily
escitalopram 20 mg every morning
levothyroxine 150 µg every morning
calcium supplements
Allergies penicillin: rash, pruritus
opioids: rash, pruritus
Family history of RLS no
Social history no cigarette or illicit drug use;
occasional alcohol consumption
RLS = restless leg syndrome.
thighs at night; sensations beginning during periods of rest
in the evening and worsening throughout the night; inability
to sit still in a theater; and sensations relieved by walking,
getting out of bed, or scratching and shaking her legs.
Review of laboratory data indicated iron studies and serum
chemistries within normal limits (Table 2). Based on her
clinical history and subjective complaints, she met diagnostic
criteria developed by the International RLS Study
Group. 9 The patient was started on pramipexole 0.125 mg
and instructed to continue zaleplon as needed.
Within 1 week, the patient reported experiencing moderate
benefit from pramipexole. Over the next 4 weeks, the
dosage was titrated to 1.5 mg at bedtime. With each dose
titration, she reported further improvement in leg movements
and self-discontinued zaleplon. Despite her beneficial
response to pramipexole, after 3 months of use, the patient
reported symptoms of polyphagia and weight gain,
akathisia, dyskinesia, and ocular gyric episodes. These
episodes were similar to her Tourette-like symptoms in
childhood. The pramipexole dose was decreased, switched
to ropinirole, and subsequently changed to carbidopa/levodopa.
Concurrently, the patient was given a prescription
for clonazepam 0.5 mg daily as needed for anxiety. Although
the patient reported similar intolerances to ropinirole
and carbidopa/levodopa, she reported that clonazepam was
beneficial for sleep initiation. Subsequently, clonazepam 0.5
mg daily as needed and 0.5–1 mg at bedtime for sleep onset
and management of RLS symptoms was prescribed.
Clonazepam monotherapy was effective in initiating
sleep and minimizing the symptoms of RLS. The patient
reported using clonazepam only at bedtime, slept 7 hours
each night, and denied abnormal movements or tics. Seven
months later, she returned to the psychiatrist with the reappearance
of RLS symptoms. The “creepy crawling” sensations
were recurring earlier, resulting in early evening ad-
Table 2. Patient Laboratory Results
Laboratory Reference
Analyte Value Range
Basic metabolic Na + 140 mEq/L 135–145
panel (Chem 7) K + 4.3 mEq/L 3.5–5
Cl – 107 mEq/L 100–110
CO2 24 mEq/L 20–30
BUN 12 mg/dL 7–25
SCr 0.9 mg/dL 0.5–1.5
glucose, random 103 mg/dL

JJ Lee et al.
ministration of clonazepam. Again, the pharmacy service
collaborated with the psychiatrist to determine possible
treatment options for RLS management.
Avoidance of dopamine agonists was preferred due to
their elicitation of abnormal movements with the patient’s
prior use. Review of literature noted several non–FDA-approved
treatment options for management of RLS. A trial
of gabapentin 100 mg at bedtime to be titrated to effectiveness
was initiated. The patient took 2 doses and self-discontinued
the medication secondary to stomach upset, pruritus,
lethargy, head tingling, lightheadedness, anxiety, and
sweating. Subsequently, tramadol 50 mg at bedtime was
initiated and was also self-discontinued after one dose due
to similar symptoms. Given the likelihood of an underlying
anxiety component, lorazepam 1 mg twice daily was
initiated for daytime use, and the patient was instructed to
continue clonazepam at bedtime for sleep and RLS.
Based on its mechanism of modulating the dopaminergic
system, a trial of bupropion XL (Wellbutrin XL) 150
mg daily was initiated. Improvement in the patient’s late
afternoon and evening RLS symptoms occurred within 3
days of use. She reported “feeling good” and discontinued
the daytime lorazepam. Furthermore, she was able to initiate
and maintain sleep for 7–8 hours nightly. Although
RLS was not completely resolved, the patient reported
continued improvements in the symptoms at 4 months.
Discussion
Management of RLS symptoms focuses on nonpharmacologic
and pharmacologic approaches. Use of mental alerting
activities, avoidance of substances or medications that
may exacerbate RLS, and addressing secondary causes of
RLS are recommended. 5,10 Other interventions include hot
baths, massage, stretching, and moderate exercise. 10 In 2004,
the Medical Advisory Board of the RLS Foundation developed
an algorithm for pharmacologic management of RLS. 5
Medication selection is based on frequency and quality of
symptoms as well as adverse effects. 2 For patients with intermittent
or daily RLS, dopamine agonists are preferred. 1,5,8
These agents should be taken 1–2 hours before symptoms
begin and titrated every 2–3 days until symptom relief is
achieved. 5 Slow upward titration is recommended to minimize
adverse effects, including nausea and orthostasis. 3
Pramipexole and ropinirole are the only FDA-approved
drugs for treatment of moderate-to-severe RLS. 11,12
Small studies have been conducted to assess efficacy of
alternative agents for management of RLS in patients who
cannot tolerate, have contraindications, or lack response to
dopamine agonists, Based on limited data, anticonvulsants,
opioids, benzodiazepines, tramadol, or clonidine may be beneficial.
13-16
A small (N = 24), randomized, double-blind, crossover
study assessed the effects of gabapentin on sensory and
motor symptoms in patients with moderate RLS. 13 Patients
were randomized to receive gabapentin or placebo for 6
weeks. After a 1-week washout period, patients were
crossed over to the alternate treatment. Patients were evaluated
at baseline and every 2 weeks thereafter using the International
RLS Study Group Rating Scale (RLS Rating
Scale), the Pittsburgh Sleep Quality Index (PSQI), and the
Clinical Global Impression of Change (CGIC). A polysomnogram
was completed at the end of each treatment
period. At the end of the study, the mean dose of gabapentin
was 1855 ± 105.6 mg and the mean RLS Rating
Scale (baseline mean 20) total score was lower following
treatment with gabapentin (9.6 ± 1.35 vs 17.9 ± 1.35; p <
0.0005). Reduction in PSQI (mean of 9.7 points at baseline)
was noted after gabapentin treatment versus placebo
(6.4 ± 0.42 vs 9.3 ± 0.42; p = 0.0001). The CGIC (1 =
much better; 7 = much worse) revealed improvement following
treatment with gabapentin (1.77 ± 0.26 vs 2.87 ±
026; p < 0.01). Compared with placebo, gabapentin treatment
was associated with a reduction in the periodic limb
movements during sleep index (11.1 ± 3.3 vs 20.8 ± 3.3; p
= 0.05). Although this study and other uncontrolled studies
have shown a beneficial response to gabapentin in RLS,
long-term efficacy has not been established. 8
The effects of carbamazepine on RLS were evaluated in
a double-blind study (N = 174). 14 Patients were randomized
to receive carbamazepine 100 mg daily (titrated weekly
to a maximum of 300 mg daily) or placebo. Frequency
of RLS attacks was recorded by each patient. Severity of
symptoms (not disturbed, severe sleep disturbance, impossible
to sleep) and therapeutic efficacy (none, good, excellent)
were reported using visual analog scales. At the end
of 5 weeks, carbamazepine was significantly more effective
than placebo in decreasing frequency of attacks (ranging
from 0 attacks per week reported in 41 subjects taking
carbamazepine vs 24 subjects taking placebo to 7 attacks
per week reported in 10 subjects taking carbamazepine vs
19 subjects taking placebo; p = 0.03), in severity of symptoms
(p < 0.01), and in subjective reports of efficacy (p <
0.1). It is worth noting that patients randomized to placebo
also reported a beneficial response in all study outcomes.
Considering carbamazepine’s adverse effects and the limited
data regarding its efficacy in RLS, it is not routinely
recommended as an alternative treatment option. 8
Opioids administered before bedtime can also be effective
for RLS management. 5,8,10 In a double-blind crossover
trial, 11 subjects with idiopathic RLS were randomized to
oxycodone or placebo for 2 weeks prior to polysomnographic
studies. 15 Agents were titrated to therapeutic effect
over 2 weeks, then tapered over 3 days before a switch was
made to the alternative treatment for 2 weeks. Over the
course of the study, oxycodone was titrated to effect (maximum
25 mg daily; mean 15 mg daily) and administered in
divided doses at night. Patients were asked to complete
372 ■ The Annals of Pharmacotherapy ■ 2009 February, Volume 43 www.theannals.com

daily ratings of leg sensations, motor restlessness, and daytime
alertness on a scale of 0– 4 (0 = none; 1 = mild; 2 =
moderate; 3 = severe; 4 = very severe). At the end of the
study, subjective ratings of leg sensations (baseline 2.65,
placebo 2.61, oxycodone 1.29; p < 0.009), motor restlessness
(baseline 2.45, placebo 2.58, oxycodone 1.21; p < 0.006),
and daytime alertness (baseline 2.15, placebo 1.79, oxycodone
1.11; p < 0.03) were significantly improved with
oxycodone. Polysomnographic reports showed improvements
in periodic limb movements per hour of sleep (baseline
38.8, placebo 52.9, oxycodone 18.4; p < 0.0004), sleep
efficiency (baseline 52.5, placebo 45.7, oxycodone 70.4; p <
0.006), and number of arousals per hour of sleep (baseline
39.1, placebo 49.1, oxycodone 26.6; p < 0.009) with oxycodone.
15 Adverse effects and potential for abuse should be
considered before using opioids for management of RLS.
Tramadol, a centrally acting nonnarcotic analgesic, may
have fewer adverse effects and a lower abuse potential
compared with opioids. Its efficacy in the management of
RLS was assessed in an open-label study (N = 12). 16 Patients
were monitored at follow-up visits at a minimum of
every 3 months for a mean of 22.8 months (range 15–26).
Tramadol dosage ranged from 50–150 mg daily. Patients
were asked to rate overall symptom severity on a scale of
0–100 (0 = no symptoms; 100 = most severe intensity
imaginable) pre- and posttreatment. The difference between
pretreatment symptom severity (range 55–100, median
90) compared with posttreatment symptom severity
(range 0–55, median 5) was statistically significant (p =
0.0039). Tramadol has limited adverse effects compared
with other RLS treatments, but more research should be
conducted before recommending widespread use of tramadol
for management of RLS.
Efficacy of benzodiazepines in RLS is less studied. Available
data indicate that benzodiazepines alone or in combination
may improve sleep quality in patients with RLS. 3 Shortacting
benzodiazepines can be effective for initiating sleep
onset, while longer-acting agents may be beneficial for patients
whose symptoms awaken them at night. 3,5 Of the drugs
available, clonazepam has been most commonly used. 8
Our case was complicated by the patient’s intolerance to
several medications. Her abnormal movements with
dopamine agonists may be explained by exacerbation of
Tourette’s syndrome caused by increased dopaminergic innervation
of striatal neurons, resulting in tics. 17 Another possible
explanation for the patient’s response to dopamine agonists
is augmentation (symptoms beginning earlier in the
evening and/or increasing in severity). 8 Treatment complications
may also result from tolerance to clonazepam monotherapy.
Furthermore, her involuntary movements may be an
indication of a concomitant movement disorder known as period
limb movement disorder (PLMD).
Although the pathophysiology of RLS is not completely
understood, disruption of dopaminergic function in the cen-
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Bupropion as a Possible Treatment Option for Restless Legs Syndrome
tral nervous system is likely involved. 3,8,18 Bupropion is an
antidepressant that inhibits dopamine and norepinephrine reuptake.
Due to the dopaminergic effects and reported efficacy
in the management of PLMD, bupropion may be a treatment
option in RLS patients. 18,19 Case reports have documented
beneficial effects of bupropion in the management of RLS
symptoms and reduction in periodic limb movements in depressed
patients. 18,19 In these reports, resolution of symptoms
occurred within 3 days of initiation of bupropion 150 mg SR
(Wellbutrin SR) daily. In one case, RLS symptoms resolved
with bupropion, reappeared when bupropion was discontinued,
and resolved again with bupropion reinitiation. 18
Our patient did not have any secondary causes for RLS,
with the exception of slightly low ferritin levels. Although
low serum ferritin concentrations are associated with RLS,
the patient was not treated with iron supplementation. Additionally,
clinicians in this case believe that the patient’s
presenting diagnoses of depression and bipolar II disorder
were erroneous. She had not been treated for either of
these disorders since her presentation to the VA. It is believed
that her underlying and untreated RLS symptoms
led to these diagnoses.
Due to the prevalence of RLS and the potential for misdiagnosis,
it is important for healthcare providers to recognize
the symptoms and treat appropriately. Dopaminergic
agents are effective for management of RLS and are considered
the treatment of choice. However, long-term use
may be associated with increased risk for adverse effects
that include daytime sedation, peripheral edema, dizziness
or lightheadedness, gastrointestinal upset, constipation,
headache, itchiness, and rash. 10
Although several drugs have been studied as possible alternative
treatment options for managing RLS symptoms,
efficacy is limited and adverse effects should be considered.
Thus far, little attention has focused on the potential benefit
of bupropion. Based on the proposed dopaminergic dysfunction
in RLS and bupropion’s effects on dopamine reuptake, it
may be a plausible alternative. This case report, in conjunction
with 3 previous reports, has suggested improvements in
unpleasant leg sensations and RLS with the use of bupropion.
However, caution must be used to avoid use of bupropion
in patients with a history of seizures, eating disorders, or a
concomitant monoamine oxidase inhibitor. Further studies
are needed before bupropion can be recommended routinely
for management of RLS symptoms.
Jennifer J Lee PharmD BCPS CDE, Assistant Clinical Professor,
School of Pharmacy, University of Connecticut, Storrs, CT; Clinical
Pharmacist, VA Connecticut Healthcare System Pharmacy Service,
West Haven, CT
Joseph Erdos MD PhD, Psychiatrist and Chief Information Officer,
Information Resources Management, VA Connecticut Healthcare
System
Meghan F Wilkosz PharmD, Clinical Pharmacy Specialist, Pharmacy
Service, VA Connecticut Healthcare System
Renee LaPlante PharmD, at time of writing, PharmD Student,
School of Pharmacy, University of Connecticut
The Annals of Pharmacotherapy ■ 2009 February, Volume 43 ■ 373

JJ Lee et al.
Brenda Wagoner PharmD, at time of writing, PharmD Student,
School of Pharmacy, University of Connecticut
Reprints: Dr. Lee, 950 Campbell Ave., West Haven, CT 06516, fax
203/937-4968, Jennifer.Lee8@va.gov
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Hansen R. Treatment of the restless legs syndrome with carbamazepine:
a double blind study. Br Med J 1984;288:444-6.
15. Walters AS, Wagner ML, Hening WA, et al. Successful treatment of
idiopathic restless legs syndrome in a randomized double-blind trial of
oxycodone versus placebo. Sleep 1993;16:327-32.
16. Laurma H, Markkula J. Treatment of restless legs syndrome with tramadol:
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17. Kenney C, Kuo SH, Jimenez-Shahed J. Tourette’s syndrome. Am Fam
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18. Kim SW, Shin IS, Kim JM, Yang SJ, Shin HY, Yoon JS. Bupropion may
improve restless legs syndrome. A report of three cases. Clin Neuropharmacol
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19. Nofzinger EA, Fasiczka A, Berman S, Thase ME. Bupropion SR reduces
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Bupropion como Posible Opción de Tratamiento para el Síndrome
de Piernas Inquietas
JJ Lee, J Erdos, MF Wilkosz, R LaPlante, y B Wagoner
Ann Pharmacother 2009;43:370-4.
EXTRACTO
OBJETIVO: Describir una paciente con el síndrome de piernas inquietas
(RLS) que fue exitosamente tratada con bupropion.
RESUMEN DEL CASO: Una señora de 45 años de edad se presentó a la clínica
de cuidado primario de la Administración de Asuntos del Veterano (VA)
con un historial de insomio crónico. Presentaba un historial complejo de
fallo terapéutico a agentes sedantes-hipnóticos, disturbios continuos de
sueño, y la queja de una sensación intolerable en las piernas. Estas circunstancias
estimularon la colaboración entre el médico siquiatra y el farmacéutico.
Al evaluar su historial médico y las quejas subjetivas que
presentaba la señora se le diagnosticó el síndrome de piernas inquietas.
A base de este nuevo diagnóstico se manejó a la paciente con varios
medicamentos aprobados por la Administración de Drogas y Alimentos
(FDA) y otros agentes alternos recomendados para el tratamiento de RLS.
Desafortunadamente, cada medicamento resultaba en efectos secundarios
intolerables lo cual limitó la lista de opciones terapéuticas. Aunque no se
utiliza ampliamente para RLS, se le prescribió a la señora bupropion XL
(Wellbutrin XL) 150 mg diarios. El síndrome de piernas inquietas
desapareció en 3 días.
DISCUSIÓN: RLS es un desorden que afecta muchas personas y puede ser
extremadamente discapacitante. Para la mayoría de los pacientes, el
tratamiento de selección para el manejo sintomático del síndrome son
los medicamentos agonistas de dopamina. Sin embargo, para pacientes
que no pueden tolerar esta clase de medicamentos, se han publicado
informes de casos y estudios pequeños identificando otras alternativas
terapéuticas. Con este informe se apoyan los resultados obtenidos en
otros casos que sugieren un efecto beneficioso de bupropion en el
manejo de RLS.
CONCLUSIONES: Bupropion puede ser una posible opción terapéutica para
pacientes con RLS que no pueden tolerar los medicamentos agonistas de
dopamina.
Traducido por Mirza Martínez
Le Bupropion comme Option de Traitement du Syndrome des
Jambes sans Repos
JJ Lee, J Erdos, MF Wilkosz, R LaPlante, et B Wagoner
Ann Pharmacother 2009;43:370-4.
RÉSUMÉ
OBJECTIF: Décrire un cas de syndrome des jambes sans repos ayant
répondu avec succès au bupropion.
PRÉSENTATION SOMMAIRE DU CAS: Une dame âgée de 45 ans se présente à
une clinique de premiers soins des Anciens Combattants pour une histoire
d’insomnie chronique. Une histoire compliquée d’échec au traitement
avec des agents sédatifs-hypnotiques, de troubles de sommeil continus,
et de plaintes de sensations intolérables au niveau des jambes a nécessité
une collaboration entre un pharmacien et un psychiatre. Une révision
supplémentaire de l’histoire médicale et des plaintes subjectives a conduit à
un diagnostic de syndrome des jambes sans repos (SJSR). En se basant
sur ce nouveau diagnostic, plusieurs alternatives approuvées par la FDA
et recommandées pour le traitement du SJSR ont été essayées chez la
patiente. Malheureusement, chaque médication a entrainé une variété
d’effets indésirables intolérables limitant la liste des options thérapeutiques.
Bien que peu utilisé pour le traitement du SJSR, le bupropion
longue action (Wellbutrin XL) a été initié à raison de 150 mg par jour et
a entrainé une résolution du problème de la patiente à l’intérieur de 3
jours.
DISCUSSION: Le SJSR peut être un désordre extrêmement handicapant
affectant plusieurs patients. Pour la plupart des patients, les agonistes
dopaminergiques sont le traitement de choix pour soulager les symptômes.
Cependant, pour les patients incapables de tolérer cette classe de
médicaments, de petits essais et des rapports de cas ont identifié des
alternatives. Le présent rapport supporte les constatations d’autres cas
suggérant une réponse bénéfique lors de l’utilisation du bupropion dans
le SJSR.
CONCLUSIONS: Le bupropion peut être une option de traitement chez les
patients souffrant du SJSR qui ne tolèrent pas les agonistes dopaminergiques.
Traduit par Marie Larouche
374 ■ The Annals of Pharmacotherapy ■ 2009 February, Volume 43 www.theannals.com