2005, Number 3
Rev Mex Neuroci 2005; 6 (3)
Comparative study between mirtazapine vs. zolpidem in insomnia associated with major depression management
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ABSTRACTIntroduction: Insomnia is a common manifestation of major depression. Administration of some antidepressant drugs could result in worsening of clinical features, because of that a symptomatic hypnotic medication may be required. Objectives: The goals of the present study were two: to determine how many patients improve their sleep in parallel with clinical antidepressant response and in those patients in which insomnia persistted, which strategy, between a sedative antidepressant or a non-benzodiazepine hypnotic, would be more efficient. Method: Major depressed patients were studied according to DSM- IV criteria. Also they must have a Hamilton test (21 items) for depression with a score higher or equal to 18 points, and insomnia is present as four points score in the three insomnia items from the HAMD. Study was divided in two parts. First part was the random administration of fluoxetine (20 mg) or venlafaxine XR (150 mg), during six weeks. In the second part, depressed patients in which insomnia persisted, were again randomized between mirtazapine (7.5 mg) and zolpidem (10 mg), a single nocturnal dose, one hour before bedtime, 12 more weeks were allowed for this second part of the study. Clinical evaluation was performed with HAMD (21 items) and Visual Analog Scale for Sleep Efficiency (VAS). Also a pharmacological side-effect list was filled out in each visit. Results: Results show that patients with fluoxetine as a group had a reduction in HAMD from baseline values (basal: 28.42 ± 2.7 vs. six weeks: 17.57 ± 5.24, Student “T” test p 0.0001), without changes in baseline sleep values at VAS (baseline: 4.57 ± 2.24 vs. 4.61 ± 1.71). The same antidepressant improvement happens in patients with venlafaxine XR (HAMD, baseline: 29.19 ± 2.4 vs. six weeks: 14.09 ± 2.79; Student “T” test p 0.0001), but sleep efficiency didn’t change, VAS (baseline: 4.4 ± 2.03 vs. six weeks: 4.11 ± 0.67). Patients with fluoxetine, seven out of 26 (26.92%) had antidepressant response at the same time as reduction in insomnia. Venlafaxine XR group had the same figures, 26.92% with simultaneous improvement on depression and insomnia. Five patients without insomnia early in the study developed this symptom with venlafaxine XR. Conclusions: The main lines of the present study were that it was an open study and that no polysomnographic studies were done, but we can establish that antidepressant response could not follow improvement in insomnia manifestation, some antidepressants may worsen the sleep quality and that mirtazapine is equivalent to zolpidem in terms of sleep improvement in depressed patients, a non-benzodiacepine hypnotic, but mirtazapine could potentiate the antidepressant effect.