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J Smok Cessat. 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?

Author information

Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, 19104.
Department of Psychiatry and Abramson Cancer Center, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, 19104.
Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, 1001 Queen Street West, Toronto, Ontario, Canada, M6J 1H4.
Department of Pharmacology & Toxicology, University of Toronto, 1 King's College Circle, University of Toronto, Toronto, Ontario, Canada, M5S 1A6.
Department of Psychology, State University of New York at Buffalo, Buffalo, NY, 14260.
Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Cancer Prevention Building (Room CPB3.3309) 1155 Pressler, Houston, TX, 77030.



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.


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


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).


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).


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

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.

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