PMID- 24450538 OWN - NLM STAT- MEDLINE DCOM- 20141028 LR - 20181202 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 30 IP - 5 DP - 2014 May TI - The impact of shift duration on the efficacy and tolerability of armodafinil in patients with excessive sleepiness associated with shift work disorder. PG - 945-51 LID - 10.1185/03007995.2014.884490 [doi] AB - OBJECTIVE: To examine the impact of night-shift duration (9 hours) on efficacy and tolerability of armodafinil in patients with shift work disorder (SWD). METHODS: This was a post hoc analysis of a 6 week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Shift workers with diagnosed SWD and late-in-shift sleepiness (between 4 am and 8 am, including the commute home) received armodafinil 150 mg or placebo before their night shift. RESULTS: Proportion of patients with at least minimal improvement in late-in-shift sleepiness, late-in-shift Clinical Global Impressions-Change (CGI-C) rating and Karolinska Sleepiness Scale (KSS), as well as overall Global Assessment of Functioning (GAF) scale and modified Sheehan Disability Scale (SDS-M), were assessed at baseline and final visit. RESULTS: Of the 383 patients enrolled, 279 (73%) worked shifts 9 hours. A greater percentage of patients receiving armodafinil had at least minimal improvement in late-in-shift CGI-C (9 hours: 77% vs 46%, P = 0.0020) regardless of shift duration. Armodafinil patients also demonstrated significantly greater improvements in GAF score (9 hours: 9.6 vs 4.3, P = 0.0019) and KSS score (9 hours: -2.8 vs -1.6, P = 0.00 28). Improvement in SDS-M composite score was significantly greater for armodafinil patients working >9 hours (-6.8 vs -2.7, P = 0.0086). Headache was the most frequent adverse event in all treatment groups. CONCLUSIONS: Patients receiving armodafinil had significantly greater improvements in late-in-shift clinical condition and in wakefulness and overall global functioning than did placebo-treated patients, regardless of shift duration. Prospectively designed, randomized clinical trials that include objective measures of sleepiness are needed to support these findings. FAU - Harsh, John AU - Harsh J AD - The Center for Sleep Medicine , Hattiesburg, MS , USA. FAU - Yang, Ronghua AU - Yang R FAU - Hull, Steven G AU - Hull SG LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20140204 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Benzhydryl Compounds) RN - 0 (Wakefulness-Promoting Agents) RN - R3UK8X3U3D (Modafinil) SB - IM MH - Adult MH - Benzhydryl Compounds/*administration & dosage/adverse effects MH - Disorders of Excessive Somnolence/*drug therapy/etiology MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Modafinil MH - Sleep Disorders, Circadian Rhythm/*drug therapy/etiology MH - Wakefulness-Promoting Agents/*administration & dosage MH - *Work Schedule Tolerance EDAT- 2014/01/24 06:00 MHDA- 2014/10/29 06:00 CRDT- 2014/01/24 06:00 PHST- 2014/01/24 06:00 [entrez] PHST- 2014/01/24 06:00 [pubmed] PHST- 2014/10/29 06:00 [medline] AID - 10.1185/03007995.2014.884490 [doi] PST - ppublish SO - Curr Med Res Opin. 2014 May;30(5):945-51. doi: 10.1185/03007995.2014.884490. Epub 2014 Feb 4.