Analysis of the side effects of tianeptine.
The evaluation of clinical and paraclinical safety of tianeptine was performed in (a) clinical pharmacology studies assessing night sleep EEG organization; electrocardiographic stability by continuous 24-h recordings (Holter's method); ocular tonus in patients with stabilized glaucoma; salivary flow; prolactin secretion; photodynamic dermatologic reactions; cerebral electrical activity; hematologic, hepatic, renal and main metabolic parameters; separately, withdrawal phenomena and addictive potential were searched for in drug addicts; (b) double-blind controlled studies versus reference compounds. The results confirm that the therapeutic safety of tianeptine is satisfactory with respect to clinical side effects and paraclinical parameters. Tianeptine does not induce sedation and thus does not disturb the recovery of active life. It does not induce anticholinergic effects (dry mouth, constipation, etc.), even in elderly subjects. It is devoid of heart and blood pressure side effects including postural hypotension tachycardia, ECG abnormalities, and especially atrioventricular or intraventricular conduction disorders. Moreover, tianeptine does not disturb the hematologic, renal, hepatic parameters, even in alcoholic patients in the detoxification period. It does not induce physical or psychological signs of dependence when discontinued, even in alcoholic patients or drug addicts. No abuse of tianeptine and no tolerance were noted in detoxified opiate addicts.
Delalleau
B
B
Institut de Recherches Internationales Servier, Neuilly-sur-Seine, France.
Dulcire
C
C
Le Moine
P
P
Kamoun
A
A
D000328:Adult; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects*; D004311:Double-Blind Method; D004361:Drug Tolerance; D004569:Electroencephalography; D006321:Heart / Q000187:drug effects; D006801:Humans; D008027:Light / Q000009:adverse effects; D008875:Middle Aged; D010276:Parasympatholytics; D011388:Prolactin / Q000378:metabolism; D019966:Substance-Related Disorders; D013841:Thiazepines / Q000009:adverse effects*
D000929:Antidepressive Agents, Tricyclic; D010276:Parasympatholytics; D013841:Thiazepines; C050504:tianeptine; D011388:Prolactin