paliperidone-palmitate and Sleep-Initiation-and-Maintenance-Disorders

Insomnia is a common feature of schizophrenia. Although several studies have been published about the influence of certain drugs on schizophrenia patients' sleep, there are no well-grounded recommendations about insomnia treatment in this clinical setting. The present review aimed to identify relevant empirical evidence on available treatments of insomnia in patients with schizophrenia, assessing their safety and efficacy.. This is a systematic review of clinical trials investigating the effect of treatments for insomnia in patients with a diagnosis of schizophrenia. Data were obtained from Medline/PubMed, Embase, PsycInfo, and the Cochrane Library. Risk of bias was assessed in individual studies for selection, performance, detection, attrition, and reporting bias.. Four studies met inclusion criteria; 2 using melatonin, 1 using paliperidone, and 1 with eszopiclone. All reported positive results: melatonin increased sleep efficiency and total duration of sleep; paliperidone decreased sleep latency onset and increased total sleep time and sleep efficiency; eszopiclone decreased insomnia severity index.. Despite a very limited number of specific studies on this matter, all 4 studies have shown good benefit/risk ratios and reviewed options-melatonin, paliperidone, and eszopiclone-might represent valid options for residual insomnia in schizophrenia.

Topics: Eszopiclone; Humans; Hypnotics and Sedatives; Melatonin; Odds Ratio; Paliperidone Palmitate; Schizophrenia; Sleep Initiation and Maintenance Disorders

Topics: Antipsychotic Agents; Central Nervous System Depressants; Humans; Isoxazoles; Melatonin; Paliperidone Palmitate; Pyrimidines; Risperidone; Schizophrenia; Sleep Initiation and Maintenance Disorders

This post hoc analysis of an open-label, single-arm, multicenter study was designed to assess the efficacy, safety, and tolerability of paliperidone extended release (ER) in Chinese patients with non-acute schizophrenia, after switching from olanzapine.. Patients with schizophrenia who were dissatisfied with prior olanzapine treatment switched to flexible paliperidone ER (3-12 mg/day) based on clinical judgment. Change from baseline to week 12 in Positive and Negative Syndrome Scale (PANSS) total scores (primary endpoint), PANSS subscale scores, response rate, Clinical Global Impression-Severity (CGI-S) score, personal and social performance (PSP) scores, patient satisfaction with treatment score, change in sleep quality, level of daytime sleepiness and safety were evaluated.. Out of 118 enrolled patients, 95 (81%) completed the study. Mean duration of study was 76.9 (23.85) days. The primary endpoint, mean (SD) PANSS total score changed significantly from baseline to endpoint (-19.6 [18.71], P <.0001). Secondary endpoints including PANSS subscale score, PSP, patient satisfaction and daytime drowsiness also significantly improved (P <.001). Most commonly reported (≥1%) treatment-emergent adverse events were akathisia (n = 14 [12%]) and insomnia (n = 9 [8%]).. Switching to flexible-dosed paliperidone ER in patients dissatisfied with prior olanzapine treatment achieved good efficacy and tolerability consistently over 12 weeks.

Topics: Adult; Akathisia, Drug-Induced; Antipsychotic Agents; China; Drug Substitution; Female; Humans; Male; Olanzapine; Paliperidone Palmitate; Patient Satisfaction; Prevalence; Prospective Studies; Schizophrenia; Sleep Initiation and Maintenance Disorders; Treatment Outcome

Paliperidone palmitate (PP) is a recently (USA) approved injectable new-generation antipsychotic. This 53-wk, Phase-III double-blind study was designed to assess the non-inferiority of PP to risperidone long-acting injectable (RIS-LAI) in schizophrenia treatment. Acutely symptomatic patients (n=749), with a Positive and Negative Syndrome Scale (PANSS) total score between 60 and 120 were randomly allocated to gluteal injections of either (a) PP: 50 mg eq. on days 1 and 8, and flexible dosing [25-100 mg eq. (i.e. 39-156 mg USA dosing)] once-monthly; or (b) RIS-LAI: bi-weekly injections of 25 mg on days 8 and 22, and flexible dosing (25-50 mg) starting from day 36, with allowed oral supplementation. Patients (n=747) were 59% men, 92% white, mean (s.d.) age of 41 (11.95) yr and 45% (n=339) completed the study. Mean (s.d.) change from baseline to endpoint in PANSS total score was: -11.6 (21.22) PP; and -14.4 (19.76) RIS-LAI (per-protocol analysis set, primary measure); least-squares means difference was -2.6 (95% CI -5.84 to 0.61), with a prespecified 5-point non-inferiority margin. PP's suboptimal dosing regimen (<150 mg eq. initial dose) resulted in lower median plasma levels of the active moiety in PP-treated vs. RIS-LAI-treated patients. Insomnia was the most common treatment-emergent adverse event, with a similar incidence in both groups (15%). PP did not demonstrate comparable efficacy to RIS-LAI, which may be attributable to the initiation dosing strategy employed. Tolerability of both treatments was comparable to previous studies, with no new safety signals detected.

Topics: Administration, Oral; Adult; Antipsychotic Agents; Buttocks; Delayed-Action Preparations; Double-Blind Method; Female; Humans; Injections, Intramuscular; Isoxazoles; Male; Paliperidone Palmitate; Palmitates; Psychiatric Status Rating Scales; Risperidone; Schizophrenia; Sleep Initiation and Maintenance Disorders; Treatment Outcome; White People

Paliperidone palmitate is an investigational, injectable atypical antipsychotic. The safety and tolerability of initiating treatment with paliperidone palmitate via deltoid versus gluteal injections given once monthly, and of switching injection sites, in adults with stable schizophrenia were assessed. In this crossover trial, stable outpatients (N=252) were randomly assigned 1:1:1 to 3 dose groups (paliperidone palmitate 50, 75, or 100 mg eq.) and 2 treatment sequences (blinded to dose): deltoid muscle (period 1 [13 weeks]) followed by gluteal muscle (period 2 [12 weeks]) or the reverse. The intent-to-treat analysis set had 249 patients: mean age=43 (SD: 12.8) years; 57% men, 81% white, baseline mean Positive and Negative Syndrome Scale (PANSS) total score=56 (SD: 11.5). A total of 170 (68%) patients completed the study, with a similar proportion completing each treatment sequence. The incidence of systemic treatment-emergent adverse events (TEAEs) was similar between the 2 injection sites across doses during period 1 (deltoid [D]: 61% to 67%; gluteus [G]: 58% to 65%), and during the last 8 weeks of the 2 study periods (DG: 32% to 45% [period 1], 29% to 42% [period 2]; GD: 31% to 40% [period 1], 30% to 41% [period 2]). During the first treatment week, median plasma paliperidone concentrations were higher with treatment initiation in the deltoid muscle compared with the gluteal muscle. At apparent steady state, there was little difference in plasma paliperidone concentrations between the deltoid and gluteus sites for a given dose. Local tolerability was slightly better with gluteal injections. Patient preference for injection sites differed between geographical regions, e.g. patients from the US preferred deltoid to gluteal sites. The most common (>or=5% overall) TEAEs were: (period 1) insomnia, anxiety, headache, and agitation; and (period 2) insomnia, psychotic disorder, weight increased, and tachycardia. Paliperidone palmitate treatment was tolerated, irrespective of injection site, and thus could offer the choice of administration into either the deltoid or gluteal muscle to meet patient and physician preference.

Topics: Adult; Buttocks; Cross-Over Studies; Double-Blind Method; Female; Headache; Humans; Injections, Intramuscular; Internationality; Isoxazoles; Male; Middle Aged; Muscle, Skeletal; Paliperidone Palmitate; Pyrimidines; Schizophrenia; Shoulder; Sleep Initiation and Maintenance Disorders

Paliperidone extended-release tablet (paliperidone ER) is an investigational oral psychotropic developed for schizophrenia treatment. It utilizes OROS technology to provide a unique pharmacokinetic profile, eliminating the need for titration and potentially leading to improved tolerability. Furthermore, paliperidone undergoes limited hepatic metabolism.. The efficacy and safety of once-daily paliperidone ER (6 mg, 9 mg and 12 mg) were assessed versus placebo in 628 patients with acute schizophrenia in a 6-week, multicenter, double-blind, randomized, parallel-group study.. All doses of paliperidone ER demonstrated significant improvement in PANSS score, all PANSS Marder factor scores (p<0.001) and personal and social functioning versus placebo (p<0.001). The PANSS total score also improved significantly in the olanzapine treatment arm. Significantly higher percentages of paliperidone ER patients demonstrated a > or =30% reduction in PANSS total score versus placebo (p<0.001). The incidence of movement disorder-related AEs and rating scales measurements were similar to placebo for the paliperidone ER 6 mg group and higher in the 9 mg and 12 mg groups. In the paliperidone ER groups there were no reports of glucose-related AEs or clinically relevant changes in plasma lipid levels and changes in mean bodyweight<1 kg.. In this study, all doses of paliperidone ER were effective in significantly improving the symptoms of schizophrenia and personal and social functioning and were generally well tolerated. Paliperidone ER offers a distinctive treatment profile and may provide a valuable new treatment option for patients with schizophrenia.

Topics: Adult; Antipsychotic Agents; Delayed-Action Preparations; Dose-Response Relationship, Drug; Drug-Related Side Effects and Adverse Reactions; Dyskinesia, Drug-Induced; Female; Humans; Isoxazoles; Male; Middle Aged; Paliperidone Palmitate; Patient Dropouts; Psychiatric Status Rating Scales; Pyrimidines; Randomized Controlled Trials as Topic; Schizophrenia; Schizophrenic Psychology; Sleep Initiation and Maintenance Disorders; Tachycardia; Treatment Outcome

This study explores relevant outcomes with flexibly dosed paliperidone extended-release (ER) in a real-world design.. Patients were recruited from 23 countries. Adults with non-acute schizophrenia (n = 1812), previously unsuccessfully treated with other oral antipsychotics, were transitioned to paliperidone ER and prospectively treated for 6 months.. Primary efficacy outcome for patients switching for the main reason of lack of efficacy was ≥ 20% improvement in Positive and Negative Syndrome Scale (PANSS) total scores. For patients switching for main reasons other than lack of efficacy, primary outcome was non-inferiority in efficacy compared with the previous medication.. Among the lack-of-efficacy group, 61% achieved a ≥ 20% improvement in PANSS total scores from baseline to endpoint. For switchers from other than the lack-of-efficacy group, efficacy maintenance after switching to paliperidone ER was confirmed. Clinically relevant and statistically significant symptomatic improvements occurred for each patient group based on main reason for switching.. Paliperidone ER was well tolerated and associated with a meaningful clinical response in patients who switched from other oral antipsychotics, with insomnia and anxiety as most frequent side-effects.

Topics: Administration, Oral; Adult; Antipsychotic Agents; Anxiety; Delayed-Action Preparations; Female; Humans; Isoxazoles; Male; Middle Aged; Paliperidone Palmitate; Prospective Studies; Pyrimidines; Schizophrenia; Sleep Initiation and Maintenance Disorders

Topics: Antipsychotic Agents; Central Nervous System Depressants; Humans; Isoxazoles; Melatonin; Paliperidone Palmitate; Pyrimidines; Risperidone; Schizophrenia; Sleep Initiation and Maintenance Disorders

Topics: Akathisia, Drug-Induced; Antipsychotic Agents; Anxiety; Clinical Trials, Phase III as Topic; Delayed-Action Preparations; Headache; Humans; Isoxazoles; Molecular Structure; Paliperidone Palmitate; Pyrimidines; Schizophrenia; Sleep Initiation and Maintenance Disorders; Tablets