From the Guidelines
Duloxetine is not considered addictive in the traditional sense, but it can cause physical dependence with long-term use. This is based on the most recent evidence from 2021, which highlights its efficacy in treating pain associated with diabetic peripheral neuropathy (DPN) without mentioning addiction as a significant concern 1. The medication works by increasing levels of serotonin and norepinephrine in the brain, helping to regulate mood, pain signals, and anxiety.
Some key points to consider about duloxetine include:
- It is a selective norepinephrine and serotonin reuptake inhibitor (SNRI) effective in treating neuropathic pain, as shown in multicenter randomized trials 1.
- Doses of 60 and 120 mg/day have been shown to be effective, although higher doses may increase the risk of adverse events, particularly in older adults 1.
- Unlike opioids, such as tapentadol, which carry a high risk of addiction and are not generally recommended as first- or second-line therapy for chronic neuropathic pain due to safety concerns and the risk of addiction 1, duloxetine does not have a significant risk of addiction.
- However, patients on duloxetine can experience withdrawal symptoms if the medication is stopped abruptly, emphasizing the need for a gradual taper when discontinuing treatment 1.
In clinical practice, it is crucial to taper duloxetine gradually over at least 2-4 weeks when discontinuing treatment to minimize the risk of withdrawal symptoms. The tapering schedule should be individualized based on the patient's response, dose, and duration of treatment. While some patients may experience side effects when starting the medication, such as nausea, dry mouth, or increased sweating, these typically improve over time and are not signs of addiction. Overall, duloxetine is a valuable option for managing neuropathic pain, particularly in diabetic patients, with a favorable profile compared to opioid analgesics in terms of addiction risk 1.
From the FDA Drug Label
- Drug Abuse and Dependence 9. 2 Abuse In animal studies, duloxetine did not demonstrate barbiturate-like (depressant) abuse potential. While duloxetine delayed-release capsules have not been systematically studied in humans for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials However, it is not possible to predict on the basis of premarketing experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. 9.3 Dependence In drug dependence studies, duloxetine did not demonstrate dependence-producing potential in rats.
Duloxetine belongs to the group of Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) medications. Regarding its potential for addiction, the drug label states that:
- Duloxetine did not demonstrate abuse potential in animal studies.
- There was no indication of drug-seeking behavior in clinical trials.
- However, as with any CNS active drug, it is not possible to predict the extent of misuse, diversion, and/or abuse once marketed. Key points to consider:
- Physicians should carefully evaluate patients for a history of drug abuse.
- Patients should be closely monitored for signs of misuse or abuse of duloxetine, such as development of tolerance or incrementation of dose 2.
From the Research
Medication Classification
Addictive Potential
- There is no clear evidence to suggest that duloxetine is addictive 3, 4, 5, 6, 7.
- However, like other antidepressants, it can cause withdrawal symptoms when stopped abruptly 3, 5.
Common Side Effects
- Common side effects of duloxetine include nausea, dry mouth, dizziness, constipation, insomnia, asthenia, and hypertension 3, 4, 5.
- Rare side effects can include acid reflux, with a reported incidence of 1.38% 6.