TABLE 13 

Summary of studies assessing the effects of pregabalin (PGB) on sleep

StudyAgeDiagnosisDesign + Number of ParticipantsResultsAdverse EventsConclusion
De Haas et al. (2007)19–67Epilepsy and subjective sleep disturbances4-wk RCT parallel-group study. PGB 300 mg/day twice a day vs. placebo twice a day. N = 17.PGB had positive effect on disturbed sleep based on subjective assessments (questionnaires) but not on polysomnographic measures. PSG reduced only the number of awakenings (P = 0.04 vs. placebo).Mild to moderate. Headache was the most frequent AE. Other AEs were dizziness and somnolence.PGB improves sleep continuity and subjective sleep quality in epileptic patients with sleep complaints.
Hindmarch et al. (2005)18–50Healthy adult volunteersRandomized, double-blind, placebo- and active-controlled, three-way crossover. PGB 150 mg three times a day vs. alprazolam 1 mg three times a day vs. placebo three times a day for 3 days. N = 24.PGB increased TST, stage N3, and sleep efficiency, and decreased SOL and REM sleep.NSPGB has significant effects on the sleep of healthy humans that are different from those of BZD; particularly, it increases SWS and sleep continuity.
Holsboer-Trachsler et al. (2013)NSGeneralized anxiety disorderReview of seven RCTs. PGB 150–600 mg/day vs. placebo.Pooled remission data in insomnia symptoms from four 4–6 wk RCTs (N = 1354): “Severe” difficulty of falling asleep, remission observed in 54.0% of PGB group vs. 29.8% of placebo group; “severe” difficulty in staying asleep, remission observed in 54.2% of PGB group vs. 26.7% of placebo group; “severe” difficulty with waking up too early, remission observed in 59.4% of PGB group vs. 34.6% of placebo group.Most frequent adverse effects, like somnolence and dizziness, are most common in first 2 wk of therapy. The incidence of somnolence as an AE in patients with moderate to severe insomnia was lower than for benzodiazepines: PGB 150 mg/day: 24.4%, PGB 300-450 mg/day: 26.2%, PGB 600 mg/day: 31.5%, alprazolam/lorazepam: 54.2%, placebo: 7.8%.PGB is effective at reducing symptoms of insomnia in generalized anxiety disorder.
Montgomery et al. (2009)Generalized anxiety disorderReview of six RCTs. N = 1854.In patients presenting with high insomnia, PGB produced significantly greater improvement on HAM-A total scores: PGB 300–450 mg/day (−13.1 ± 0.6); PGB 600 mg/day (−11.2 ± 0.5) dose groups compared with placebo (−8.3 ± 0.5; P < 0.0001 for both comparisons). PGB 150 mg/day was not significant (−9.9 ± 0.7; P = 0.051).Total discontinuations were lower than placebo (25.9%) for pregabalin 150 mg/day (16.4%) and 300–450 mg/day (16.4%), nonsignificantly higher for pregabalin 600 mg (27.6%), and significantly higher for alprazolam/lorazepam (38.0%, respectively; P < 0.05.PGB 300–600 mg/day is effective at reducing symptoms of anxiety in patients presenting with generalized anxiety disorder with high levels of insomnia.
Russell et al. (2009)18+FibromyalgiaReview of two RCTs. PGB 300, 450, or 600 mg/day vs. placebo. N = 1493.Both studies found significant improvement in PGB group relative to placebo group on: Sleep Quality Diary and MOS Subscales of Sleep Disturbance, Quantity of Sleep, and Sleep Problems Index. Pooled results not listed.Not analyzed.PGB is effective at reducing symptoms of insomnia in fibromyalgia.