Sleep disturbances and sleep disorders in adults living with chronic pain: a meta-analysis.

Pregabalin is an antagonist of voltage gated Ca2+ channels and specifically binds to alpha-2-delta subunit to produce antiepileptic and analgesic actions. It successfully alleviates the symptoms of various types of neuropathic pain and presents itself as a first line therapeutic agent with remarkable safety and efficacy. Preclinical studies in various animal models of neuropathic pain have shown its effectiveness in treating the symptoms like allodynia and hyperalgesia. Clinical studies in different age groups and in different types of neuropathic pain (peripheral diabetic neuropathy, fibromyalgia, post-herpetic neuralgia, cancer chemotherapy-induced neuropathic pain) have projected it as the most effective agent either as monotherapy or in combined regimens in terms of cost effectiveness, tolerability and overall improvement in neuropathic pain states. Preclinical studies employing pregabalin in different neuropathic pain models have explored various molecular targets and the signaling systems including Ca2+ channel-mediated neurotransmitter release, activation of excitatory amino acid transporters (EAATs), potassium channels and inhibition of pathways involving inflammatory mediators. The present review summarizes the important aspects of pregabalin as analgesic in preclinical and clinical studies as well as focuses on the possible mechanisms.

/pdf/pregabalin-in-neuropathic-pain-evidences-and-possible-1won5ut8pz.pdf

Pregabalin in neuropathic pain: evidences and possible mechanisms

Cognitive behavioral therapy for insomnia in patients with chronic pain - A systematic review and meta-analysis of randomized controlled trials.

Sleep disturbances in fibromyalgia: A meta-analysis of case-control studies.

Introduction: Fibromyalgia is a syndrome characterized by chronic generalized pain in addition to different symptoms such as fatigue, sleep disturbances, stiffness, cognitive impairment, and psychological distress. Multidisciplinary treatment combining pharmacological and nonpharmacological therapies is advised.Areas covered: Publications describing randomized controlled trials and long-term extension studies evaluating drug treatment for fibromyalgia were searched in PubMed and Scopus and included in this review.Expert opinion: Different drugs are recommended for the treatment of fibromyalgia by different published guidelines, although only three of them have been approved for this indication by the US FDA, and none have been approved by the European Medicines Agency. According to the available evidence, pregabalin, duloxetine and milnacipran should be the drugs of choice for the treatment of this disease, followed by amitriptyline and cyclobenzaprine. Other drugs with at least one positive clinical tria...

An update on pharmacotherapy for the treatment of fibromyalgia.

OBJECTIVE To investigate the effect of pregabalin on wake and sleep bout parameters. MATERIALS AND METHODS A post hoc analysis of polysomnography data from a randomized, placebo-controlled, crossover study investigating the effect of pregabalin (150 to 450 mg/d) and placebo on sleep in fibromyalgia (FM). Eligible patients had FM and sleep-maintenance problems, including wake after sleep onset ≥45 minutes and total sleep time (TST) 3.0 to 6.5 hours, but no other sleep/circadian rhythm disorders. Polysomnography was performed for 2 consecutive nights (screening, post-treatment). Wake and sleep bout duration and frequency were derived; a "bout"=consecutive 30-s epochs of sleep or wake. RESULTS Of 119 patients randomized (103 [87%] female), data were available for 103 treated with pregabalin and 106 with placebo. Pregabalin versus placebo treatment decreased mean±SD number of wake/sleep bouts (33.24±1.33 vs. 36.85±1.32; difference: -3.61 [95% confidence interval, -6.03, -1.18]; P=0.0039) and increased sleep bout duration (15.25±0.63 vs. 11.58±0.62 min; +3.67 min [2.22, 5.12 min]; P<0.0001). Pregabalin decreased mean duration of wake bouts versus placebo (3.41±0.55 vs. 3.94±0.55 min; -0.53 min [-1.06, -0.002 min]; P=0.0493). An exploratory correlation analysis of treatment effects found stage 1 sleep was negatively correlated with wake and sleep bout duration and positively with wake/sleep bout number; slow wave sleep (%total sleep time) was positively correlated with wake and sleep bout duration and negatively with wake/sleep bout number. CONCLUSIONS Pregabalin improved sleep parameters characteristic of disturbed sleep in FM, by preventing awakenings and increasing sleep bout duration. These effects are reflected in, and correlated with, a decrease in "light sleep" (stage 1) and an increase in "deep sleep" (slow wave sleep).

Pregabalin Improves Fibromyalgia-related Sleep Disturbance

Objective:To investigate the differential nature of disturbed sleep in patients with fibromyalgia (FM) reporting sleep difficulties versus patients with primary insomnia (PI) and patients who do not report disturbed sleep (pain-free controls).Materials and Methods:Patients (FM: n=132; PI: n=109; nor

Characteristics of Disturbed Sleep in Patients With Fibromyalgia Compared With Insomnia or With Pain-Free Volunteers.

Effect of pregabalin on quantitative electroencephalography (qeeg) during non-rem sleep in patients with fibromyalgia and sleep maintenance difficulties

Objective
To assess the effect of pregabalin on polysomnographic (PSG) measures of sleep and patient-rated sleep, tiredness, and pain in fibromyalgia patients.

Methods
We performed a randomized, double-blind, placebo-controlled, 2-period crossover PSG study. Patients ages ≥18 years with fibromyalgia satisfied subjective and objective sleep disturbance criteria prior to randomization. Eligible patients were randomized (1:1) to pregabalin (300–450 mg/day) or placebo for crossover period 1, and vice versa for period 2. Each crossover period comprised a dose-adjustment and dose-maintenance phase, with a 2-week taper/washout between periods. In-laboratory PSGs were recorded during 2 consecutive nights at screening and at the end of each crossover period. The primary end point was the difference in sleep maintenance defined by PSG-recorded wake after sleep onset (WASO; minutes) between 4 weeks of treatment with pregabalin and with placebo. Other PSG measures; patient-rated sleep, tiredness, and pain; and tolerability were assessed.

Results
Of 119 patients randomized (103 women [86.6%], mean age 48.4 years), 102 (85.7%) completed both periods. Patients treated with pregabalin showed a reduction in PSG-determined WASO versus treatment with placebo (week 4 difference: −19.2 minutes [95% confidence interval (95% CI) −26.7, −11.6]; P < 0.0001). Pain score improved (decreased) with pregabalin versus placebo treatment at all 4 weeks (week 4 difference: −0.52 [95% CI −0.90, −0.14]; P = 0.0084). Modest (ρ = <0.3) but significant correlations were found between PSG sleep assessments and ratings of pain and sleep quality. Frequently reported all-causality adverse events (pregabalin versus placebo) were: dizziness (30.4% versus 9.9%), somnolence (20.5% versus 4.5%), and headache (8.9% versus 8.1%).

Conclusion
Patients with fibromyalgia treated with pregabalin had statistically significant and meaningful improvements in sleep, as assessed by PSG. Patients with fibromyalgia also reported decreased daily pain. Pregabalin was well tolerated.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/acr.21595

Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study.

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Pregabalin Improves Fibromyalgia-related Sleep Disturbance

Characteristics of Disturbed Sleep in Patients With Fibromyalgia Compared With Insomnia or With Pain-Free Volunteers.

Effect of pregabalin on quantitative electroencephalography (qeeg) during non-rem sleep in patients with fibromyalgia and sleep maintenance difficulties

Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study.