Buprenorphine Transdermal System’s Impact on Sleep

Phoenix—After 12 weeks of treatment, adult patients with chronic lower back pain who received 20 mcg per hour of buprenorphine using the buprenorphine transdermal system (BTS) experienced less sleep disturbance and better sleep quality compared with those who received 5 mcg per hour, according to a phase 3, multicenter, randomized, double-blind active comparator trial.

Results were presented during a poster session at the AAPM meeting. The poster was titled Buprenorphine Transdermal System Impacts Sleep for Back Pain.

In 2010, the FDA approved the BTS to continuously deliver 5 mcg, 10 mcg, or 20 mcg of buprenorphine, a semi-synthetic partial mµ-opioid agonist and a Schedule III controlled substance, for 7 days. The BTS is intended for patients with moderate-to-severe chronic pain who require a continuous opioid analgesic for an extended period of time.

Previous trials had found that the 20-mcg BTS was safe, effective, and well tolerated in treating chronic low back pain. In this analysis, the authors examined the effectiveness of the 5-mcg and 20-mcg BTS in patients with chronic lower back pain.

Before entering the 12-week double-blind period, patients enrolled in an open-label run-in period to determine the responsiveness and tolerability of the 20-mcg BTS. Patients could also enter an extension phase that began 3 days after the double-blind phase and lasted up to 12 months.

The double-blind period began with everyone receiving the 5-mcg BTS for ≥3 days, with some patients then switching to a higher dose. The authors collected data at baseline, at the end of the run-in period, at weeks 4, 8, and 12 of the double-blind phase, and at weeks 4, 8, 12, 16, 20, 24, and 52 of the extension phase.

To measure sleep quality and sleep problems, the authors used the Medical Outcomes Study Sleep Scale (MOS-Sleep), a 12-item self-reported survey that examined disturbance, snoring, awakening at night due to shortness of breath or headache, adequacy, somnolence, and quantity of sleep. They were scored on a 1-100 scale, with higher scores indicating better sleep outcomes. The authors also calculated a Sleep Problems Index (SPI) score as a standardized T-score based on the distribution of scores with the United States population for 2009.

The authors used several statistical methods to determine the results, including analysis of covariance, analysis of variance, linear mixed-models, and regression models.

When patients finished the 12-week double-blind phase, the 20-mcg BTS group had significantly better adjusted mean scores for the sleep disturbance domain (P<.01) and the SPI (P<.05) compared with the 5-mcg BTS group. After 12 weeks, there was no difference in snoring, breath/headache, adequacy, or somnolence between the groups.

The advantage in the 20-mcg BTS group for disturbance appeared within 4 weeks of the double-blind phase. Patients in the 20-mcg BTS group improved their sleep outcomes during the run-in period, which continued throughout the double-blind phase. During the 52-week extension period, there was no degradation of disturbance or SPI scores, and the results were consistent at each study visit (week 4, 8, 12, 16, 20, 24, and 52).

The analysis also included a comparison of sleep quality and problems for patients with chronic lower back pain with a sample of the United States general population. The authors adjusted the results of a 2009 Internet survey to reflect age and gender differences.

At baseline, patients with chronic lower back pain had significantly worse scores on disturbance, adequacy, and SPI (P<.001) and an advantage compared with the general population on the snoring, breath/headache, and somnolence domains (P<.001). After 12 weeks, patients in the 5-mcg BTS group had statistically equivalent disturbance and SPI scores compared with the general population, while those in the 20-mcg BTS group had significantly better disturbance and SPI scores compared with the general population (P<.001).