Nicotine replacement therapy for tobacco dependence
ATC code: N07BA01 (Nicotine)
Brand names
Nicorette, Nicotinell, NiQuitin, Nicabate
An agonist of nicotinic acetylcholine receptors (nAChR), preferentially α4β2 in the CNS. Nicotine replacement therapy (NRT) delivers controlled nicotine via patches, gum, lozenges, spray – without harmful tobacco smoke components (tar, carbon monoxide, carcinogens). Reduces withdrawal severity and cravings. Smoking cessation effect confirmed in over 50 RCTs (Cochrane 2018, RR 1.55 vs placebo).
First line
First-line for smoking cessation per NG209 (2021) and 2021. Combining long-acting (patch 14 or 21 mg over 24 or 16 hours) and short-acting (gum 2 or 4 mg as needed, lozenge, nasal or oral spray) raises efficacy over monotherapy. Course 8–12 weeks with gradual dose reduction. Efficacy comparable to and varenicline; combined with behavioral support – best outcomes.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Nicotine in patches, gum, and snus is taken by healthy non-smoking adults as a cognitive enhancer for concentration. 2021 limits nicotine replacement therapy to patients with tobacco dependence for smoking cessation. Nicotine is a highly addictive substance that can produce dependence even in non-smokers, sometimes quickly. Use carries risks of nicotine dependence, elevated blood pressure, increased heart rate, headache, and nausea. In young adults nicotine disrupts prefrontal cortex development. If nicotine is being taken for concentration, consider seeking a second opinion: attention problems usually have other causes (sleep deprivation, ADHD, anxiety) treated per diagnosis.
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FDA category D. Nicotine crosses the placenta and is linked to fetal growth restriction, preterm birth, SIDS. First-line for smoking in pregnancy is behavioral therapy and psychological support; NRT is used only when quitting otherwise is impossible, under supervision.
Nicotine passes into milk. NRT is preferred over active smoking. Defer breastfeeding for 2–3 hours after fast-acting forms (gum, lozenges, spray).
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Nicotine is evaluated for the following indications with varying evidence strength: Smoking cessation (evidence tier A), Memory and concentration enhancement (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Nicotine (≥ 1 in 100): Skin irritation under the patch, Nausea, Headache, Insomnia and vivid dreams, Oral mucosa irritation (gum and lozenges), Cough (nasal spray). See the Safety section for uncommon and serious reactions.
FDA category D. FDA category D. Nicotine crosses the placenta and is linked to fetal growth restriction, preterm birth, SIDS. First-line for smoking in pregnancy is behavioral therapy and psychological support; NRT is used only when quitting otherwise is impossible, under supervision.
Nicotine passes into milk. NRT is preferred over active smoking. Defer breastfeeding for 2–3 hours after fast-acting forms (gum, lozenges, spray).
Nicotine is contraindicated in: Hypersensitivity to nicotine or excipients; Age under 12; Pregnancy – with caution (preferable in non-smoking pregnant patients); Acute MI (first 2 weeks); Unstable angina. Full list in the Safety section.