From the Guidelines
Duloxetine (Cymbalta) is primarily indicated for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain, with a recommended starting dose of 30 mg once daily for one week, then increasing to 60 mg once daily, and potentially up to 120 mg daily for pain conditions. The medication has been shown to be effective in reducing pain in patients with painful diabetic peripheral neuropathy, with approximately 50% of patients achieving at least 50% pain reduction at doses of 60 or 120 mg/day 1. The number needed to treat (NNT) to achieve at least 50% pain reduction was 4.9 for 120 mg/day and 5.2 for 60 mg/day, indicating a favorable efficacy profile 1.
Some of the common side effects of duloxetine include:
- Nausea
- Somnolence
- Dizziness
- Constipation
- Dry mouth
- Reduced appetite These side effects are generally mild to moderate and transient, with no association with weight gain 1.
It is essential to note that duloxetine should not be taken with MAOIs or thioridazine, and alcohol should be avoided during treatment. The medication works by increasing serotonin and norepinephrine levels in the brain, which helps regulate mood, reduce anxiety, and decrease pain perception. Patients should be aware that abrupt discontinuation can cause withdrawal symptoms, so dosage should be gradually reduced when stopping treatment. The most recent evidence suggests that duloxetine is a viable treatment option for patients with diabetic peripheral neuropathic pain, with a favorable balance of efficacy and tolerability 1.
From the FDA Drug Label
Duloxetine delayed-release capsules may be taken with or without food. If you miss a dose of duloxetine delayed-release capsules, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of duloxetine delayed-release capsules at the same time The most common side effects of duloxetine delayed-release capsules include: nausea dry mouth sleepiness fatigue constipation loss of appetite increased sweating dizziness
The indications of Duloxetine are not explicitly stated in the provided drug labels. The dosing instructions for Duloxetine are to take the capsules exactly as the healthcare provider tells you to, swallowing them whole without chewing or crushing. The potential side effects of Duloxetine include:
- Liver damage
- Changes in blood pressure and falls
- Serotonin Syndrome
- Abnormal bleeding
- Severe skin reactions
- Discontinuation symptoms
- Manic episodes
- Visual problems
- Seizures or convulsions
- Low salt (sodium) levels in the blood
- Nausea
- Dry mouth
- Sleepiness
- Fatigue
- Constipation
- Loss of appetite
- Increased sweating
- Dizziness 2
From the Research
Indications for Duloxetine
- Duloxetine is indicated for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic osteoarthritis pain and low back pain 3, 4.
- It is also approved for the treatment of stress urinary incontinence 4, 5.
- Additionally, duloxetine may be effective in treating mood spectrum disorders, panic disorder, and certain symptom clusters of borderline personality disorder, as well as an add-on drug in schizophrenia 6.
Dosing of Duloxetine
- The recommended dosing of duloxetine is 60 mg once-daily for the management of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic osteoarthritis pain and low back pain 3.
- For the treatment of MDD and GAD, the recommended dosing is 40-60 mg per day, given either as a single dose or divided into two doses 5.
- The maximum recommended dose of duloxetine is 120 mg per day 5.
Potential Side Effects of Duloxetine
- Common side effects of duloxetine include nausea, dry mouth, dizziness, constipation, insomnia, asthenia, and hypertension 3, 5.
- Duloxetine may also cause increases in blood pressure and pulse, particularly at higher doses 5.
- Other potential side effects include serotonin syndrome, particularly when combined with MAOIs, and dysuria, which is a common and troublesome side effect of milnacipran, a similar medication 5.
- Duloxetine may also interact with other medications, including CYP1A2 inhibitors, CYP2D6 inhibitors, and benzodiazepines, which may increase the risk of adverse effects 7.