TY - JOUR
T1 - Effect of lisdexamfetamine dimesylate on sleep in adults with attention-deficit/hyperactivity disorder
AU - Adler, Lenard A.
AU - Goodman, David
AU - Weisler, Richard
AU - Hamdani, Mohamed
AU - Roth, Thomas
N1 - Funding Information:
This study was supported by Shire Development Inc, Wayne, PA. Although the study sponsor was involved in the study design, and collection, analysis and interpretation of data, the ultimate interpretation of the data was made by the independent authors, as was the writing of this manuscript and the decision to submit this manuscript for publication in Behavioral and Brain Functions. Editorial assistance was provided by Michael Pucci, PhD, of Health Learning Systems, part of CommonHealth®.
Funding Information:
Dr Weisler receives/d research support from the National Institute of Mental Health, Pfizer, Lilly, GlaxoSmithKline, Abbott, Merck, Organon, Bioavail, Shire, Sanofi-Synthe-labo, AstraZeneca, Janssen, Wyeth Ayerst, Solvay, Novartis, Schwabe/Ingenix, Bristol-Myers Squibb, TAP Pharmaceutical, Synaptic Pharmaceutical Incorporated, Eisai, UCB Pharma, Inc., Cephalon, Lundbeck, Forest, Pharmacia, Neurochem, Cenerx, Eli Lilly, Ciba-Geigy, Vela, Parke Davis, Sandoz, Upjohn, MediciNova, SmithK-line Beecham, Saegis, Corcept, New River Pharmaceuticals, McNeil, Burroughs Wellcome, CoMentis, Johnson & Johnson, Takeda, Sepracor, Repligen, and Dainnpon-Sumitomo. He is/has been a speaker for Wyeth Ayerst, Solvay, GlaxoSmithKline, Lilly, AstraZeneca, Cephalon, Validus, Bioavail, Abbott, Forest, Bristol-Myers Squibb, Shire, Pfizer, Eli Lilly, Organon, and Sanofi. He is/has been a consultant for ATSDR (Agency for Toxic Solvent Disease Registry), CDC (Centers for Disease Control), Bristol-Myers Squibb, Bioavail, Lilly, Wyeth Ayerst, Shire, Organon, Sanofi-Synthelabo, Forest, Solvay, Johnson & Johnson, Novartis, Ostuka America Pharma, Corcept, Abbott, Pfizer, GlaxoSmithKline, and Validus. He is/has been a financial stockholder of Merck, Pfizer, Bristol-Myers Squibb, Cortex, Abbott, and Johnson & Johnson.
PY - 2009/8/3
Y1 - 2009/8/3
N2 - Background: Sleep problems are common in adults with attention-deficit/ hyperactivity disorder (ADHD). This analysis aimed to evaluate the impact of lisdexamfetamine dimesylate (LDX) on sleep quality in adults with ADHD. Methods: This 4-week, phase 3, double-blind, forced-dose escalation study of adults aged 18 to 55 years with ADHD randomized participants to receive placebo (n = 62), or 30 (n = 119), 50 (n = 117), or 70 (n = 122) mg/d LDX, taken once a day in the morning. The self-rated Pittsburgh Sleep Quality Index (PSQI) was administered at baseline and at week 4 to assess sleep quality. The PSQI global score assesses 7 sleep components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) each scored from 0 (no difficulty) to 3 (severe difficulty). Results: The mean baseline PSQI global score was 5.8 for LDX and 6.3 for placebo (P = .19) indicating poor overall sleep quality. At endpoint, least squares (LS) mean change from baseline was -0.8 for LDX vs -0.5 for placebo (P = .33). The daytime functioning component showed significant improvement in LS mean change at endpoint for LDX compared with placebo (LDX -0.4 vs placebo 0.0, P = .0001). LS mean changes for the other 6 PSQI components did not significantly differ from placebo. Sleep-related treatment-emergent adverse events with an incidence ≥2% in the active treatment and placebo groups, respectively, were insomnia (19.3% and 4.8%), initial insomnia (5.0% and 3.2%), middle insomnia (3.6% and 0%), sleep disorder (0.6% and 3.2%), somnolence (0.3% and 3.2%), and fatigue (4.7% and 4.8%), and were generally mild or moderate in severity. Conclusion: For most subjects, LDX was not associated with an overall worsening of sleep quality and significantly improved daytime functioning in adults with ADHD.
AB - Background: Sleep problems are common in adults with attention-deficit/ hyperactivity disorder (ADHD). This analysis aimed to evaluate the impact of lisdexamfetamine dimesylate (LDX) on sleep quality in adults with ADHD. Methods: This 4-week, phase 3, double-blind, forced-dose escalation study of adults aged 18 to 55 years with ADHD randomized participants to receive placebo (n = 62), or 30 (n = 119), 50 (n = 117), or 70 (n = 122) mg/d LDX, taken once a day in the morning. The self-rated Pittsburgh Sleep Quality Index (PSQI) was administered at baseline and at week 4 to assess sleep quality. The PSQI global score assesses 7 sleep components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) each scored from 0 (no difficulty) to 3 (severe difficulty). Results: The mean baseline PSQI global score was 5.8 for LDX and 6.3 for placebo (P = .19) indicating poor overall sleep quality. At endpoint, least squares (LS) mean change from baseline was -0.8 for LDX vs -0.5 for placebo (P = .33). The daytime functioning component showed significant improvement in LS mean change at endpoint for LDX compared with placebo (LDX -0.4 vs placebo 0.0, P = .0001). LS mean changes for the other 6 PSQI components did not significantly differ from placebo. Sleep-related treatment-emergent adverse events with an incidence ≥2% in the active treatment and placebo groups, respectively, were insomnia (19.3% and 4.8%), initial insomnia (5.0% and 3.2%), middle insomnia (3.6% and 0%), sleep disorder (0.6% and 3.2%), somnolence (0.3% and 3.2%), and fatigue (4.7% and 4.8%), and were generally mild or moderate in severity. Conclusion: For most subjects, LDX was not associated with an overall worsening of sleep quality and significantly improved daytime functioning in adults with ADHD.
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U2 - 10.1186/1744-9081-5-34
DO - 10.1186/1744-9081-5-34
M3 - Article
C2 - 19650932
AN - SCOPUS:69549107725
SN - 1744-9081
VL - 5
JO - Behavioral and Brain Functions
JF - Behavioral and Brain Functions
M1 - 34
ER -