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The efficacy of pregabalin and benzodiazepines in generalized anxiety disorder presenting with high levels of insomnia
International Clinical Psychopharmacology, 06/25/09

Montgomery SA et al. - Pregabalin was well tolerated, and improved overall anxiety symptoms, while specifically improving insomnia in patients with generalized anxiety disorder presenting with high levels of concurrent insomnia.

• Pooled data were analyzed from six double-blind, placebo-controlled, 4- to 6-week trials of outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (fourth edition) criteria for GAD with a minimum Hamilton Rating Scale for Anxiety (HAM-A) score = 18.
• Response was evaluated for three fixed-dose PGB groups (150, 300-450, 600 mg/day), and for a benzodiazepine group (alprazolam or lorazepam).
• A 'high-insomnia' subgroup was defined by a baseline HAM for Depression (HAM-D) insomnia factor score greater than 3 (maximum = 6).

• At baseline, 1002 (54%) patients met the criteria for the high-insomnia subgroup, and 852 (46%) for the low-insomnia subgroup.
• Mean baseline HAM-A scores were 1-2 points higher in high-insomnia versus low-insomnia patients.
• In high-insomnia patients, PGB produced significantly greater improvement in HAM-A total scores at last observation carried forward endpoint on 300-450 mg (-13.1±0.6) and 600 mg (-11.2±0.5) dose groups compared with placebo (-8.3±0.5; P<0.0001 for both comparisons)
• Improvement on PGB 150 mg was not significant (-9.9±0.7; P = 0.051).
• Improvement was significant in the benzodiazepine group (-11.0±0.6; P<0.0001).
• In the high-insomnia subgroup, treatment with PGB significantly (P<0.001) improved the HAM-D insomnia factor scores on both the 300-450 mg (-2.73) and 600 mg (-2.35) doses, and on benzodiazepines (-2.52) compared with placebo (-1.51)
• Improvement on PGB 150 mg (-1.69) was not significant.
• Rates of treatment-emergent insomnia were lower on PGB compared with placebo in both the high- and low-insomnia subgroups.

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