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Treatment of Severe Sleep Disorder Psychiatria Danubina, 2013; Vol. 25, No. 4, pp 416-418 Case report © Medicinska naklada - Zagreb, Croatia TREATMENT OF SEVERE SLEEP DISORDER RELATED TO ALCOHOL-DEPENDENCE WITH HIGH-DOSE AGOMELATINE – A CASE REPORT Martin Grosshans¹, Jochen Mutschler2 & Falk Kiefer¹ 1 Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Mannheim, University of Heidelberg/Medical Faculty Mannheim, Germany 2 Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Zürich, Switzerland received: 7.7.2013; revised: 25.9.2013; accepted: 18.10.2013 * * * * * INTRODUCTION liver-enzyme activity as an adverse effect under therapy with the drug. This led the European Medicines Agency Among abstinent alcohol-dependent (AD) patients, to recommend routine liver-function tests as a precau- sleep disorders are a wide-spread and persistent problem tionary measure prior to the onset and after 6 weeks, 12 entailing the risk of relapsing into drinking (Brower weeks, and 12 months of treatment with agomelatine 2003). The polysomnographic characteristics of AD (EMA 2012). It should be noted that agomelatine is patients include prolonged sleep-latency and decreased contraindicated in patients with impaired hepatic func- sleep-efficiency (Brower et al. 2001). Furthermore, tion, for example due to cirrhosis or active liver disease. abstinent alcohol-dependent patients show abnormal evening melatonin-profiles (Kuhlwein et al. 2003). CASE REPORT However, although a variety of pharmacological sub- stances (hypnotics, sedative antidepressants, anticonvul- “Mr. G.”,a 67-year old male patient, has received sants, antipsychotics) are available, the treatment of ambulatory treatment in our outpatient clinic since 2007. alcohol-related sleep disorders is often complicated by Critical alcohol consumption set in at the age of 21. From various adverse side-effects, i.g. dependence, daytime- the age of about 45 he has been addicted to alcohol. Over sedation, weight gain, and sexual dysfunction. The latter the years in our outpatient care, Mr. G. had to undergo is a particularly unpopular and frequent side effect of one fully and one partially inpatient detoxification, each many antidepressants, markedly reducing life quality in the wake of a relapse. For more than half a year now, and leading to poor compliance (Papakostas 2008). the patient has been consistently abstinent, regularly Agomelatine, a structural analog of melatonin, is an attending our outpatient clinic (every two weeks). In agonist for the MT1 and MT2 receptors and a 5-HT2C addition, he is participating in a supervised self-help antagonist, representing a new class of antidepressants. group for alcoholics meeting in our department once a It has been approved for the treatment of adults with week. The patient is married and sexually active, major depression (de Bodinat et al. 2010). The re- watching his physical fitness and body weight. commended dose-range of agomelatine for this indica- Over the last eight years, Mr. G. has developed tion is 25-50 mg/day. However, early phase-I trials severe chronic sleep disorders in association with his indicated the drug to be well tolerated (in daily doses alcohol dependence, with difficulties in both falling and from 5 to 1200 mg), with 800 mg being defined as the remaining asleep (suffering from prolonged periods of maximal well-tolerated dose based on one subject who wakefulness and frequent early-morning awakening). experienced postural dizziness with 1200 mg. Even in For many years, his insomnia was treated by the family high doses, agomelatine was not associated with pro- doctor. Among the drugs from various classes of nounced adverse effects: the most common ones were psychotropic agents (tricyclic antidepressants, sedative mild sedation and headache (Kasper & Hamon 2009, antipsychotic agents) administered in the course of time, Olie & Kasper 2007). This was encouraging, in view of only two compounds turned out to be effective in the tolerability problems associated with other anti- inducing sleep to the patient’s satisfaction: mirtazapine depressants (Papakostas 2008). As to sexual function, and zolpidem. During 6 months of treatment, agomelatine, other than for instance paroxetine, effected mirtazapine normalized the sleeping pattern, but the no impairment in sexually active healthy volunteers patient refused to continue taking it due to inacceptable (Montejo et al. 2010). hyperphagia-associated weight gain (over 5 kg in 8 However, the documentation of post-marketing expe- weeks) and sexual dysfunction with impaired erectility rience with agomelatine includes reports on increases in and delayed orgasms. The patient responded well to 416 Martin Grosshans, Jochen Mutschler & Falk Kiefer: TREATMENT OF SEVERE SLEEP DISORDER RELATED TO ALCOHOL-DEPENDENCE WITH HIGH-DOSE AGOMELATINE – A CASE REPORT Psychiatria Danubina, 2013; Vol. 25, No. 4, pp 416–418 zolpidem, but after 8 months of intermittent prescriptions DISCUSSION the family doctor refrained from further prescribing the drug on account of its habit-forming potential, requesting Based on its mechanism of action at melatonin our department to take over the management of the receptors, agomelatine appears to be a promising patient’s insomnia. alternative off-label medication for the treatment of After taking over, we talked with the patient on the sleep disturbances in AD patients. Moreover, due to its possibility of an off-label therapy of his sleep disorders positive side-effect profile (in particular, no weight with agomelatine (symptoms of depression were not gain and no impairment of sexual functions), it holds present, Ham-D21: 9 points, BDI: 8 points). We informed out the prospective of becoming a valuable asset in the him of the potential liver toxicity of agomelatine, and pharmacological repertoire of sleep medicine. How- hence of the necessity to regularly control his liver ever, considering the possibly adverse effects of ago- function under treatment. It was pointed out to the patient melatine on liver functions (the risk of liver damage is that the drug would be prescribed only in small units, and increased in AD patients, anyhow) the use of this that in case of a relapse into alcohol consumption the substance in AD patients may be controversial. The treatment would be stopped at once. Following detailed reported case demonstrates severe AD-associated sleep clarification, the patient consented to undergo a therapy disturbances to be a heavy burden for the patients trial with agomelatine under the conditions just affected. The available pharmacological options for a elaborated on. long-term treatment are either contraindicated due to Prior to the onset of therapy the patient’s sleeping their abuse potential (hypnotics) or badly tolerated due problems were specified and quantified by means of the to their adverse side-effects on bodyweight and sexual Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. functions (antipsychotics, antidepressants, anticon- 1989). The PSQI is a questionnaire for self-rating sleep vulsants). quality and sleep disturbances. Nineteen individual items Thus, agomelatine appears to be a treatment option generate 7 “component” scores: subjective sleep-quality, for a subgroup of AD patients. This assumption has sleep latency, sleep duration, habitual sleep-efficiency, been corroborated by the successful treatment of our sleep disturbances, use of sleep medication, and daytime patient. However, we recommend the off-label use of dysfunction. The sum of the 7 scores yields the global agomelatine for the treatment of AD-associated sleep score. disturbances only if the following criteria are met: (I) Liver-enzyme activity was controlled by laboratory The patient is well-known and considered to be tests for determining plasma transaminases. The test reliable, is regularly attending an outpatient depart- results were normal before the treatment. The ment or private practice, and is informed in detail of agomelatine therapy started with 25 mg/day. The sleeping the drug’s potential liver toxicity and the necessity of pattern showed no improvement. After 3 weeks the instantly discontinuing the treatment in case of a dosage was doubled. With 50 mg/day, the patient had no relapse into alcohol consumption. (II) Before starting problems to fall asleep, but could not sleep through, treatment any impairment of liver function must be waking up after 2-3 hours. Four weeks later we increased diagnosed, while under treatment the liver function has the dose to 75 mg/day, thereby exceeding the to be checked regularly by monitoring the liver recommended maximal daily dosage. With this amount transaminases in the plasma. (III) Agomelatine is only of agomelatine, the patient could not only fall asleep prescribed in small units. quickly, but also maintain sleep, to his satisfaction, for Based on premarketing phase-I-data documenting about five and a half hours each night. He reported his high doses of agomelatine (up to 800 mg/day) to be daytime tiredness had abated considerably; he was now tolerated well, we decided to increase the daily dosage capable of reading with concentration and of better in the present case to 75 mg/day, notwithstanding the pursuing other hobbies, for instance sport. He felt maximum dosage of 50 mg/day recommended by the agomelatine to be less effective than zolpidem had been, manufacturer. The increase beyond 50 mg/day may be but in the dosage of 75 mg it ensured him a sufficiently indicated in
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