fluvoxamine and Sleep-Initiation-and-Maintenance-Disorders

Sleep disturbances are among the most commonly endorsed symptoms of post-traumatic stress disorder (PTSD). Treatment modalities that are effective for the waking symptoms of PTSD may have limited efficacy for post-traumatic sleep problems. The aim of this review is to summarize the evidence for empirically supported and/or utilized psychotherapeutic and pharmacological treatments for post-traumatic nightmares and insomnia. While there are few controlled studies of the applicability of general sleep-focused interventions to the management of the sleep disturbances in PTSD, evidence is growing to support several psychotherapeutic and pharmacological treatments. Future investigations should include trials that combine treatments focused on sleep with treatments effective in managing the waking symptoms of PTSD.

Topics: Antipsychotic Agents; Cognitive Behavioral Therapy; Dreams; Eye Movement Desensitization Reprocessing; Fluvoxamine; Humans; Piperazines; Prazosin; REM Sleep Behavior Disorder; Restless Legs Syndrome; Serotonin and Noradrenaline Reuptake Inhibitors; Sleep; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Stress Disorders, Post-Traumatic; Trazodone; Triazoles

The discontinuation of many pharmacologic agents is associated with characteristic withdrawal symptoms. Antidepressants, particularly the tricyclic antidepressants (TCAs), are known to be associated with a group of common symptoms upon discontinuation. Serotonin reuptake inhibitors (SRIs) are also taking their respective place in the literature with reports of discontinuation symptoms. This review summarizes case reports and reports that allow systematic assessment of discontinuation symptoms following SRI discontinuation.. A computerized literature search was conducted using a MEDLINE search to identify reports of withdrawal effects following discontinuation of SRIs. Additional reports were found in the bibliographies of various published reports.. SRI discontinuation symptoms in adults are summarized in 24 case reports and 9 reports from controlled clinical trials. Additionally, 3 case reports addressing SRI discontinuation in the neonate are described. The reports describe clusters of symptoms commonly associated with the discontinuation of an SRI.. We propose to define an antidepressant discontinuation syndrome as the onset of a cluster of somatic and psychic symptoms following the discontinuation of an SRI and not attributable to other causes (e.g., concomitant medication, illness). These symptoms include dizziness, light-headedness, insomnia, fatigue, anxiety/agitation, nausea, headache, and sensory disturbance. The syndrome may last up to 3 weeks and may be improved by restarting the antidepressant or starting an antidepressant with a similar pharmacologic profile.

Topics: 1-Naphthylamine; Adolescent; Adult; Child; Clinical Trials as Topic; Cyclohexanols; Dizziness; Female; Fluoxetine; Fluvoxamine; Headache; Humans; Infant; Infant, Newborn; Male; MEDLINE; Mental Disorders; Middle Aged; Nausea; Paroxetine; Selective Serotonin Reuptake Inhibitors; Sensation Disorders; Sertraline; Sleep Initiation and Maintenance Disorders; Substance Withdrawal Syndrome; Venlafaxine Hydrochloride

Sleep disturbances are commonly observed in mood disorders, and sleep manipulations can influence the clinical status. In the present study, we investigated the possible effect of the 3111 T/C circadian locomotor output cycles kaput (CLOCK) gene polymorphism on insomnia symptomatology during antidepressant treatment. One hundred seventy-eight inpatients were treated with fluvoxamine 300 mg/day (n = 147) or paroxetine 20-40 mg/day (n = 31), and either placebo or pindolol in a double blind design for 6 weeks. The severity of depressive symptoms was weekly assessed with the Hamilton Rating Scale for Depression (HAM-D). We observed a significantly higher presence of insomnia throughout the trial in homozygotes for the C variant (P = 0.026). Other demographic and clinical features were found not to be related with CLOCK polymorphisms. Overall, our findings may suggest that CLOCK genotype influences the time course of insomnia during antidepressant treatment. This, together with previous findings on this polymorphism could lead to a further dissection of the complexity of mood disorders.

Topics: Adult; Aged; Antidepressive Agents; CLOCK Proteins; Double-Blind Method; Drug Therapy, Combination; Female; Fluvoxamine; Gene Frequency; Genotype; Humans; Male; Middle Aged; Mood Disorders; Multivariate Analysis; Paroxetine; Pindolol; Polymorphism, Genetic; Serotonin Antagonists; Sleep Initiation and Maintenance Disorders; Time Factors; Trans-Activators; Treatment Outcome

Fatigue is a major clinical problem in many patients with primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC). An effective treatment has not been defined. Recently, a large proportion of patients with these diseases was found to have symptoms of depression. Because fatigue is a frequent symptom of depression and there is some evidence that treatment with an antidepressant improves fatigue in patients with fibromyalgia, we hypothesised that the antidepressant fluvoxamine might improve fatigue related to PBC and PSC.. Fatigued patients were randomised to receive fluvoxamine (75 mg BID) or placebo for a six-week period. Fatigue and quality of life were quantified using a visual analogue scale, the Fisk Fatigue Severity Scale, the Multidimensional Fatigue Inventory and the SF-36.. Seventeen and 16 patients were allocated to fluvoxamine and placebo, respectively. There was no statistically significant beneficial effect of fluvoxamine on fatigue or quality of life. The median VAS scores in the fluvoxamine and placebo groups were 7.40 and 7.45 at day 0, 6.9 and 7.15 at day 14, 7.45 and 7.65 at day 42 and 7.8 and 8.0 four weeks after treatment discontinuation.. We found no evidence for a beneficial effect of fluvoxamine on fatigue in these patients with cholestatic liver disease and severe chronic fatigue.

Topics: Cholangitis, Sclerosing; Dizziness; Fatigue; Female; Fluvoxamine; Headache; Humans; Liver Cirrhosis, Biliary; Male; Middle Aged; Nausea; Sleep Initiation and Maintenance Disorders; Treatment Outcome

The aim of this 12-week, double-blind, flexible-dose, placebo-controlled, parallel-arm, multicenter trial was to determine the safety and efficacy of fluvoxamine in a controlled-release (CR) formulation in adult outpatients with obsessive-compulsive disorder (OCD).. 253 adult outpatients with DSM-IV OCD were randomly assigned to receive 100 to 300 mg of fluvoxamine CR (N = 127) or placebo (N = 126) once daily for 12 weeks. Intent-to-treat analyses of efficacy assessments with the Yale-Brown Obsessive Compulsive Scale (YBOCS), Clinical Global Impressions-Severity of Illness scale (CGI-S), and Clinical Global Impressions-Improvement scale (CGI-I) were conducted.. Fluvoxamine CR was significantly (p <.05) superior to placebo in decreasing YBOCS total score beginning at week 2. This early response was sustained at all subsequent visits. At endpoint, there was a mean decrease of 8.5 +/- 0.7 (31.7%) in the YBOCS total score compared with baseline in the fluvoxamine CR treatment group versus a mean decrease of 5.6 +/- 0.7 (21.2%) in the placebo group (p =.001). Fluvoxamine CR was also significantly superior to placebo in lowering the severity of illness (CGI-S, p =.002) and in producing clinical improvement (CGI-I, p <.01). At endpoint, significantly greater percentages of the fluvoxamine CR treatment group were responders (p =.002) and remitters (p =.019) compared with the placebo group.. Over 12 weeks, fluvoxamine CR treatment was associated with a statistically significant and clinically relevant reduction in OCD severity and was found to be safe and well tolerated. The early onset of therapeutic effect, starting from week 2, was of particular interest.

Topics: Adolescent; Adult; Aged; Ambulatory Care; Delayed-Action Preparations; Double-Blind Method; Female; Fluvoxamine; Humans; Male; Middle Aged; Nausea; Obsessive-Compulsive Disorder; Placebos; Psychiatric Status Rating Scales; Selective Serotonin Reuptake Inhibitors; Sleep Initiation and Maintenance Disorders; Treatment Outcome

This study assesses the efficacy of fluvoxamine treatment on different domains of subjective sleep quality in Vietnam combat veterans with chronic posttraumatic stress disorder (PTSD). Medically healthy male Vietnam theater combat veterans (N = 21) completed a 10-week open label trial. Fluvoxamine treatment led to improvements in PTSD symptoms and all domains of subjective sleep quality. The largest effect was for dreams linked to the traumatic experience in combat. In contrast, generic unpleasant dreams showed only a modest response to treatment. Sleep maintenance insomnia and the item "troubled sleep" showed a large treatment response, whereas sleep onset insomnia improved less substantially. These therapeutic benefits contrast with published reports that have found activating effects of Selective Serotonin Reuptake Inhibitors on the sleep electroencephalogram.

Topics: Adult; Aged; Fluvoxamine; Humans; Male; Middle Aged; Personality Disorders; Psychiatric Status Rating Scales; Selective Serotonin Reuptake Inhibitors; Severity of Illness Index; Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic; Treatment Outcome

Serotonergic agents appear to be effective treatments for premenstrual symptoms in a number of small trials. The purpose of this open-label treatment study was to collect pilot information on the efficacy of fluvoxamine for premenstrual dysphoric disorder (PDD).. Twelve women who sought medical treatment for premenstrual symptoms were evaluated. The main outcome measure was the premenstrual score from daily symptom reports (DSRs) maintained by the subjects. After a 2-month screening period, 10 subjects who met DSM-IV criteria for PDD were treated with fluvoxamine taken daily for two menstrual cycles. The mean dose at 4 weeks was 85 mg/day; at 8 weeks, all subjects took 100 mg/day.. The mean premenstrual DSR scores improved at 4 weeks from the pretreatment baseline (paired t test, p < .0008) and remained improved at 8 weeks at approximately the same level (p < .003). Symptoms with the greatest improvement (p < .003, significant with the Bonferroni adjustment) were irritability, anxiety, feeling out of control, and decreased interest in usual activity. Sixty percent (6/10) of the subjects reported at least a 50% reduction in the DSR scores, a conservative clinical definition of improvement. The mean premenstrual Hamilton Rating Scale for Depression scores decreased from 19 at the pretreatment baseline to 9 at the 4-week evaluation. The main side effects were insomnia (N = 6), fatigue (N = 4), dry mouth (N = 4), and nausea (N = 3) and were generally mild and transient.. These promising pilot data show the importance of a controlled trial over a longer time period to provide definitive information on the efficacy of fluvoxamine for premenstrual dysphoric disorder.

Topics: Adolescent; Adult; Depressive Disorder; Drug Administration Schedule; Fatigue; Female; Fluvoxamine; Humans; Menstrual Cycle; Middle Aged; Nausea; Pilot Projects; Premenstrual Syndrome; Psychiatric Status Rating Scales; Severity of Illness Index; Sleep Initiation and Maintenance Disorders; Treatment Outcome

To examine the efficacy of fluvoxamine and clomipramine in obsessive compulsive disorder and to compare their tolerabilities.. In this multicenter, randomized, double-blind trial, fluvoxamine (100-250 mg/day) was compared with clomipramine (100-250 mg/day) for 10 weeks in the treatment of 66 psychiatric outpatients, aged 18 to 65 years, with a diagnosis of obsessive compulsive disorder. The main efficacy variable was the Yale-Brown Obsessive Compulsive Scale; secondary variables were the National Institute of Mental Health Global Obsessive Compulsive Scale and the Clinical Global Impressions-Improvement scale.. Seventeen patients withdrew prematurely, 6 in the fluvoxamine group and 11 in the clomipramine group. In the intent-to-treat population (34 fluvoxamine patients and 30 clomipramine patients), there were no significant differences with respect to the mean reduction in total Yale-Brown Obsessive Compulsive Scale score (last observation carried forward) at any time-point; a mean reduction of 8.6 (33%) was seen in the fluvoxamine group and 7.8 (31%) in the clomipramine group. Similar results were obtained in virtually all secondary variables. The only exception was the obsession-free interval for the Yale-Brown Obsessive Compulsive Scale, which was significantly longer in the fluvoxamine group, especially in a population of patients with disease of > 12 months' duration (F = 5.298, df = 1, p = .026). Adverse events were mostly tolerable; 9 patients (5 receiving fluvoxamine, 4 receiving clomipramine) withdrew due to adverse events related to treatment.. Fluvoxamine and clomipramine were equally effective in the treatment of obsessive compulsive disorder. Both agents were well tolerated; fluvoxamine produced fewer anticholinergic side effects and caused less sexual dysfunction than clomipramine, but more reports of headache and insomnia.

Topics: Adult; Ambulatory Care; Clomipramine; Double-Blind Method; Female; Fluvoxamine; Headache; Humans; Male; Obsessive-Compulsive Disorder; Patient Dropouts; Psychiatric Status Rating Scales; Sleep Initiation and Maintenance Disorders; Treatment Outcome

Outpatients with major affective disorder, unipolar depressed type (N=101), were treated in a 4-week placebo-controlled double-blind study to compare the efficacy and safety of fluvoxamine, a new serotonin reuptake inhibitor antidepressant, with imipramine and placebo. Therapy was initiated at 50 mg/day; thereafter, dosage ranged between 100 and 300 mg/day for both drugs. Results indicate statistically significant efficacy, measured by both patient and physician rating scales, for both active drugs over placebo. Fluvoxamine showed some evidence of earlier onset of action. Anticholinergic side effects were more common in the imipramine-treated patients, while fluvoxamine produced more gastrointestinal distress and insomnia.

Topics: Adult; Aged; Ambulatory Care; Antidepressive Agents; Clinical Trials as Topic; Depressive Disorder; Double-Blind Method; Female; Fluvoxamine; Humans; Imipramine; Male; Middle Aged; Nausea; Oximes; Patient Dropouts; Placebos; Psychiatric Status Rating Scales; Sleep Initiation and Maintenance Disorders; Vomiting; Xerostomia

Topics: Circadian Rhythm; Cytochrome P-450 Enzyme System; Drug Therapy, Combination; Female; Fluvoxamine; Humans; Hydrocortisone; Melatonin; Middle Aged; Selective Serotonin Reuptake Inhibitors; Sleep; Sleep Initiation and Maintenance Disorders; Treatment Outcome

The cytochrome enzyme P450 2D6 (CYP2D6) is thought to play a role in the human metabolism of fluvoxamine. Levomepromazine is a potent inhibitor of CYP2D6. We coadministered a low dosage of levomepromazine and fluvoxamine in 15 patients and found that the low dosage of levomepromazine was effective in counteracting the fluvoxamine-induced insomnia and did not increase plasma fluvoxamine levels. These results suggest that the inhibition of CYP2D6 by levomepromazine has little effect on fluvoxamine metabolism. Therefore, a low dosage of levomepromazine, used as a hypnotic agent, appears to be effective and safe when coadministered with fluvoxamine. Since this was a pilot study without a placebo control, a double-blind placebo-controlled study is needed to confirm our preliminary findings.

Topics: Adult; Aged; Aged, 80 and over; Cytochrome P-450 CYP2D6 Inhibitors; Depressive Disorder, Major; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Fluvoxamine; Humans; Male; Methotrimeprazine; Middle Aged; Panic Disorder; Sleep Initiation and Maintenance Disorders; Treatment Outcome