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. 2017 Jun;12(2):63-70.
doi: 10.1017/jsc.2016.11. Epub 2016 Apr 12.

Sleep Disturbance During Smoking Cessation: Withdrawal or Side Effect of Treatment?

Rebecca L Ashare  1 , Caryn Lerman  2 , Rachel F Tyndale  3   4 , Larry W Hawk  5 , Tony P George  3 , Paul Cinciripini  6 , Robert A Schnoll  2
Affiliations

Sleep Disturbance During Smoking Cessation: Withdrawal or Side Effect of Treatment?

Rebecca L Ashare et al. J Smok Cessat. 2017 Jun.

Abstract

Introduction: The nicotine-metabolite ratio (NMR) predicts treatment response and is related to treatment side effect severity. Sleep disturbance may be one important side effect, but understanding sleep disturbance effects on smoking cessation is complicated by the fact that nicotine withdrawal also produces sleep disturbance.

Aims: To evaluate the effects of withdrawal and treatment side effects on sleep disturbance.

Methods: This is a secondary analysis of data from a clinical trial (Lerman et al., 2015) of 1,136 smokers randomised to placebo (n = 363), transdermal nicotine (TN; n = 381), or varenicline (n = 392) and stratified based on NMR (559 slow metabolisers; 577 normal metabolisers). Sleep disturbance was assessed at baseline and at 1-week following the target quit date (TQD). We also examined whether sleep disturbance predicted 7-day point-prevalence abstinence at end-of-treatment (EOT).

Results: The varenicline and TN groups exhibited greater increases in sleep disturbance (vs. placebo; treatment × time interaction; p = 0.005), particularly among those who quit smoking at 1-week post-TQD. There was a main effect of NMR (p = 0.04), but no interactions with treatment. TN and varenicline attenuated withdrawal symptoms unrelated to sleep (vs. placebo). Greater baseline sleep disturbance predicted relapse at EOT (p = 0.004).

Conclusions: Existing treatments may not mitigate withdrawal-related sleep disturbance and adjunctive treatments that target sleep disturbance may improve abstinence rates.

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Conflict of interest statement

Conflict of Interest CL received study medication and placebo, and support for medication packaging, from Pfizer; she has also consulted to Gilead, and has been a paid expert witness in litigation against tobacco companies. PC served on the scientific advisory board of Pfizer Pharmaceuticals, did educational talks sponsored by Pfizer on smoking cessation from 2006 to 2008, and has received grant support from Pfizer. RAS received medication and placebo free of charge from Pfizer for a different project, and has consulted to Pfizer and GlaxoSmithKline. TPG has had both investigator-initiated and industry-sponsored grants from Pfizer in the past 12 months, and serves on a data monitoring committee for Novartis. RFT has acted as a consultant to pharmaceutical companies, primarily on smoking cessation. The remaining authors declare no competing interests.

Figures

Figure 1
Figure 1
Sleep disturbance score at baseline (Pre-Quit) and 1-week post-TQD by treatment arm among all subjects. Data presented are reaw values. Error bars are standard error
Figure 2
Figure 2
Sleep disturbance score at pre-quit and 1-week Post-TQD by treatment arm and abstinence status at 1-week Post-TQD (smoking n = 627 vs. abstinent n = 509). Among those who were abstinent, all groups exhibited an increase in sleep disturbance, but the effect was significantly large in the TN and varenicline groups, compared to the placebo group (treatment arm × visit interaction, p = 0.03). In contrast, among those who either never quit smoking or relapsed, there was no treatment × visit interaction (p = 0.25). The three-way NMR × treatment arm × abstinence status interaction was not significant. Mean +/−standard error
Figure 3
Figure 3
Change in sleep disturbance and modified MNWS from baseline (Pre-Quit) to 1-week post-TQD by treatment arm among all subjects. Error bars are standard error
See this image and copyright information in PMC

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