{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T16:19:42Z","timestamp":1780589982878,"version":"3.54.1"},"reference-count":30,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2012,3,27]],"date-time":"2012-03-27T00:00:00Z","timestamp":1332806400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis Care &amp; Research"],"published-print":{"date-parts":[[2012,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To assess the effect of pregabalin on polysomnographic (PSG) measures of sleep and patient\u2010rated sleep, tiredness, and pain in fibromyalgia patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed a randomized, double\u2010blind, placebo\u2010controlled, 2\u2010period crossover PSG study. Patients ages \u226518 years with fibromyalgia satisfied subjective and objective sleep disturbance criteria prior to randomization. Eligible patients were randomized (1:1) to pregabalin (300\u2013450 mg\/day) or placebo for crossover period 1, and vice versa for period 2. Each crossover period comprised a dose\u2010adjustment and dose\u2010maintenance phase, with a 2\u2010week taper\/washout between periods. In\u2010laboratory 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\u2010recorded wake after sleep onset (WASO; minutes) between 4 weeks of treatment with pregabalin and with placebo. Other PSG measures; patient\u2010rated sleep, tiredness, and pain; and tolerability were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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\u2010determined WASO versus treatment with placebo (week 4 difference: \u221219.2 minutes [95% confidence interval (95% CI) \u221226.7, \u221211.6]; <jats:italic>P<\/jats:italic> &lt; 0.0001). Pain score improved (decreased) with pregabalin versus placebo treatment at all 4 weeks (week 4 difference: \u22120.52 [95% CI \u22120.90, \u22120.14]; <jats:italic>P<\/jats:italic> = 0.0084). Modest (\u03c1 = &lt;0.3) but significant correlations were found between PSG sleep assessments and ratings of pain and sleep quality. Frequently reported all\u2010causality 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%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acr.21595","type":"journal-article","created":{"date-parts":[[2012,1,9]],"date-time":"2012-01-09T13:30:51Z","timestamp":1326115851000},"page":"597-606","source":"Crossref","is-referenced-by-count":61,"title":["Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: A randomized, placebo\u2010controlled, 2\u2010way crossover polysomnography study"],"prefix":"10.1002","volume":"64","author":[{"given":"Thomas","family":"Roth","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. Alan","family":"Lankford","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pritha","family":"Bhadra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ed","family":"Whalen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E. Malca","family":"Resnick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2012,3,27]]},"reference":[{"key":"e_1_2_8_2_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780330203"},{"key":"e_1_2_8_3_2","doi-asserted-by":"publisher","DOI":"10.1002\/acr.20140"},{"key":"e_1_2_8_4_2","first-page":"69","article-title":"Hypersomnolence in fibromyalgia syndrome","volume":"20","author":"Sarzi\u2010Puttini P","year":"2002","journal-title":"Clin Exp Rheumatol"},{"key":"e_1_2_8_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0304-3959(96)03226-5"},{"key":"e_1_2_8_6_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.23828"},{"key":"e_1_2_8_7_2","first-page":"1586","article-title":"Effects of selective slow wave sleep disruption on musculoskeletal pain and fatigue in middle aged women","volume":"26","author":"Lentz MJ","year":"1999","journal-title":"J Rheumatol"},{"key":"e_1_2_8_8_2","doi-asserted-by":"publisher","DOI":"10.1097\/00006842-197601000-00006"},{"key":"e_1_2_8_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2007.10.022"},{"key":"e_1_2_8_10_2","first-page":"1113","article-title":"Sleep cycles and \u03b1\u2010\u03b4 sleep in fibromyalgia syndrome","volume":"21","author":"Branco J","year":"1994","journal-title":"J Rheumatol"},{"key":"e_1_2_8_11_2","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(200101)44:1<222::AID-ANR29>3.0.CO;2-K"},{"key":"e_1_2_8_12_2","first-page":"1193","article-title":"Cyclic alternating pattern: a new marker of sleep alteration in patients with fibromyalgia?","volume":"31","author":"Rizzi M","year":"2004","journal-title":"J Rheumatol"},{"key":"e_1_2_8_13_2","unstructured":"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Questions and answers about fibromyalgia (NIH publication no. 09\u20105326).2009. URL:http:\/\/www.niams.nih.gov\/Health_Info\/Fibromyalgia\/default.asp."},{"key":"e_1_2_8_14_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.20983"},{"key":"e_1_2_8_15_2","first-page":"502","article-title":"A randomized, double\u2010blind, placebo\u2010controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia","volume":"35","author":"Mease PJ","year":"2008","journal-title":"J Rheumatol"},{"key":"e_1_2_8_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpain.2008.03.013"},{"key":"e_1_2_8_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2009.01.009"},{"key":"e_1_2_8_18_2","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/28.2.187"},{"key":"e_1_2_8_19_2","doi-asserted-by":"crossref","first-page":"473","DOI":"10.5664\/jcsm.26911","article-title":"Exploratory polysomnographic evaluation of pregabalin on sleep disturbance in patients with epilepsy","volume":"3","author":"De Haas S","year":"2007","journal-title":"J Clin Sleep Med"},{"key":"e_1_2_8_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2008.02.027"},{"key":"e_1_2_8_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.rdc.2009.05.008"},{"key":"e_1_2_8_22_2","doi-asserted-by":"publisher","DOI":"10.1097\/00000441-199806000-00005"},{"key":"e_1_2_8_23_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1533-2500.2009.00352.x"},{"key":"e_1_2_8_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3999(02)00545-7"},{"key":"e_1_2_8_25_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11926-011-0209-3"},{"key":"e_1_2_8_26_2","doi-asserted-by":"publisher","DOI":"10.1097\/00006842-197507000-00008"},{"key":"e_1_2_8_27_2","doi-asserted-by":"publisher","DOI":"10.1016\/0013-4694(91)90122-K"},{"key":"e_1_2_8_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbspin.2008.01.021"},{"key":"e_1_2_8_29_2","doi-asserted-by":"publisher","DOI":"10.3109\/00207459708988479"},{"key":"e_1_2_8_30_2","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/27.4.741"},{"key":"e_1_2_8_31_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2009.09.003"}],"container-title":["Arthritis Care &amp; Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Facr.21595","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/acr.21595","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,2]],"date-time":"2025-10-02T14:22:45Z","timestamp":1759414965000},"score":1,"resource":{"primary":{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/10.1002\/acr.21595"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,3,27]]},"references-count":30,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2012,4]]}},"alternative-id":["10.1002\/acr.21595"],"URL":"https:\/\/doi.org\/10.1002\/acr.21595","archive":["Portico"],"relation":{},"ISSN":["2151-464X","2151-4658"],"issn-type":[{"value":"2151-464X","type":"print"},{"value":"2151-4658","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,3,27]]}}}