What is the prescriber information for Amitriptyline (Tricyclic Antidepressant)?

From the Guidelines

Amitriptyline should be started at a low dose of 10-25 mg at bedtime and gradually increased as tolerated, with careful monitoring for side effects and therapeutic response, particularly in older adults due to its anticholinergic effects 1. The typical starting dose for adults with depression is 25-50 mg at bedtime, gradually increasing to 150-300 mg daily if needed. For chronic pain or migraine prevention, lower doses of 10-25 mg at bedtime are often effective, with gradual increases as tolerated. Some key points to consider when prescribing amitriptyline include:

• The medication should be taken consistently, preferably in the evening due to its sedative effects.
• Common side effects include drowsiness, dry mouth, constipation, blurred vision, and weight gain.
• The medication works by increasing levels of serotonin and norepinephrine in the brain, which helps regulate mood and pain perception.
• Patients should be aware that therapeutic effects may take 2-4 weeks to develop fully.
• Amitriptyline should not be stopped abruptly but tapered gradually under medical supervision.
• It carries contraindications for patients with certain heart conditions, glaucoma, urinary retention, or those taking MAO inhibitors.
• Regular monitoring for side effects and therapeutic response is essential, particularly during the initial treatment period, as supported by recent guidelines 1.
• Tricyclic antidepressants, such as amitriptyline, are potentially inappropriate for older adults (aged ≥65 years) due to their anticholinergic effects, as noted in a 2022 study 1.
• However, amitriptyline is often used and recommended for patients with fibromyalgia, although evidence for its effectiveness is limited, as mentioned in a 2022 guideline 1.
• A 2021 study provides guidance on the use of tricyclic antidepressants, such as amitriptyline, for irritable bowel syndrome, recommending a starting dose of 10 mg once a day and titrating slowly to a maximum of 30–50 mg once a day 1.

From the FDA Drug Label

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with amitriptyline hydrochloride and should counsel them in its appropriate use A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions” is available for amitriptyline hydrochloride. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.

The prescriber information for Amitriptyline includes:

• Informing patients, their families, and caregivers about the benefits and risks associated with treatment
• Counseling patients on the appropriate use of amitriptyline hydrochloride
• Providing a patient Medication Guide to help patients understand the treatment
• Instructing patients to read the Medication Guide and assisting them in understanding its contents
• Giving patients the opportunity to discuss the contents of the Medication Guide and answer any questions they may have 2

From the Research

Prescriber Information for Amitriptyline

• Amitriptyline is a tricyclic antidepressant agent that also has analgesic properties 3
• It is used to treat chronic neuropathic pain and fibromyalgia, and is recommended in many guidelines 4
• The dosage of amitriptyline for chronic pain management can vary, but low doses (≤25 mg) are commonly used 5
• Factors associated with the prescription of traditional doses (>25 mg) of amitriptyline include male sex, age 65-80 years, headaches, and concomitant use of benzodiazepines or zolpidem 5
• Amitriptyline has been shown to be effective in reducing pain and disability in patients with chronic low back pain, although the evidence is limited 6
• The efficacy of amitriptyline for chronic pain management is supported by second-tier evidence, which suggests that it can be an effective treatment option for patients with neuropathic pain and fibromyalgia 4
• However, the use of amitriptyline for chronic pain management is not without risks, and patients should be monitored closely for adverse events such as dry mouth, sedation, and orthostatic hypotension 3, 4

Dosage and Administration

• The dosage of amitriptyline for chronic pain management can vary, but low doses (≤25 mg) are commonly used 5, 6
• The dose can be escalated as needed, but patients should be monitored closely for adverse events 3, 4
• Amitriptyline can be taken orally, and the dosage can be adjusted based on the patient's response to treatment 3, 4

Safety and Efficacy

• Amitriptyline has been shown to be effective in reducing pain and disability in patients with chronic low back pain, although the evidence is limited 6
• The efficacy of amitriptyline for chronic pain management is supported by second-tier evidence, which suggests that it can be an effective treatment option for patients with neuropathic pain and fibromyalgia 4
• However, the use of amitriptyline for chronic pain management is not without risks, and patients should be monitored closely for adverse events such as dry mouth, sedation, and orthostatic hypotension 3, 4