*An off-label use of a medication is a use that is not FDA-approved. Prescribers can decide to use a medication off-label because, in their professional judgment, they believe it may offer a benefit to someone.
Amitriptyline treats depression in adults. It can prevent suicidal thoughts or attempts and improve mood and feelings of well-being, relieve anxiety and tension, improve sleep quality, and increase energy levels. Furthermore, it has been effective in treating post-COVID headaches. However, some people may experience changes in their appetite and weight when they start taking it. It may occasionally cause drowsiness and other side effects.
If you’re considering amitriptyline, online psychiatry platforms such as Talkiatry and Brightside Health can connect you with a provider quickly. They offer assessments and can provide a prescription if they determine amitriptyline or another medication may help your symptoms.
Boxed Warning: Amitriptyline (Elavil) – Risk of suicidal thoughts and behaviors
Amitriptyline, the active ingredient in Elavil, has a black box warning. These are the most serious types of warnings from the Food and Drug Administration (FDA). Amitriptyline can increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Regardless of your age, you should talk with your doctor about serious risks with amitriptyline and any other medications before starting treatment.
What Is Elavil (Amitriptyline)?
Amitriptyline is a tricyclic antidepressant (TCA) to treat depression and anxiety in adults.1 It is a first-line preventive treatment for migraines with sleep disturbances and irritable bowel syndrome (IBS). It increases serotonin and norepinephrine hormones in the brain to regulate mood and behavior. Amitriptyline is safe and the drug of choice during breastfeeding.2 The brand name version, Elavil, was discontinued, but it remains available in its generic form. It is not approved for use by anyone younger than 12 years old unless under the supervision of a specialist. However, older adults and adolescents may use the lower doses.
How Does Amitriptyline Work?
Amitriptyline may improve depression symptoms by increasing brain-derived neurotrophic factor (BDNF) levels. Stress reduces BDNF levels, and long-term treatment with amitriptyline can raise them to relieve depression symptoms. BDNF is an important neurotrophin (protein), and studies have indicated its lower blood levels in depressed individuals.3
Is Amitriptyline a Sleeping Pill?
Amitriptyline is not specifically considered a sleeping pill. However, its ‘off-label’ use to treat insomnia (sleeplessness) is due to its sedative effect. It is known to improve sleep onset and maintenance due to its long-acting duration. It may also indirectly improve sleep by treating mood disorders or headaches.4
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What Is Amitriptyline Used to Treat?
Amitriptyline is an FDA-approved drug to treat major depressive disorder (MDD) in adults. FDA-approved means the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. Young people aged 16 to 17 can also take its low dose for depression or low mood. However, it is not approved for use in children under 12 years of age due to limited safety information. Specialists weigh the risks with the clinical condition if they consider prescribing it to children, adolescents, or young adults.
Amitriptyline may also be used as an off-label (non-FDA-approved) treatment for several conditions. Prescribers can decide to use a medication off-label because, in their professional judgment, they believe it may offer a benefit to someone. Off-label uses for amitriptyline include treating chronic fatigue and pain, sleep disturbances, fibromyalgia, migraines, and several other conditions. Amitriptyline may also be used to treat post-COVID headaches.5
Side Effects of Amitriptyline
Amitriptyline may cause side effects in some individuals due to its direct action, although many experience no side effects or only minor ones. These effects are generally mild and usually subside within a few days as the body adjusts to the drug.
It is important to closely monitor and observe individuals for worsening symptoms and unusual changes in behavior, particularly during the first few months of therapy or when there are changes in the dosage, whether it is an increase or decrease. Using the smallest drug dose can avoid the risk of overdose and ensure good disease management.
Common Side Effects of Amitriptyline
Common side effects are mild and may disappear within a few days or weeks. People may find appetite and weight changes when they start taking it. Avoid operating machinery or going outdoors during the first few days of taking the drug, as it may cause drowsiness and dizziness. If you experience any of these side effects that do not go away, contact your doctor or seek medical help immediately.1
Common side effects of amitriptyline include:*1, 7
- Increased or decreased sex drive (libido, impotence)
- Weight gain and constipation
- Dry mouth
- Dizziness
- Headache
- Sleepiness
- Blurry vision
- Difficulty urinating
*All medications, including amitriptyline, can cause side effects that can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and understand the potential side effects and benefits of any medication.
Serious Side Effects of Amitriptyline
Although rare, serious side effects of amitriptyline may occur either due to its direct effect or in combination with other drugs. Seek emergency medical help if you experience new or worsening symptoms listed below.
Serious side effects of amitriptyline may include:*1, 7
- Heart failure and arrhythmias
- Psychosis and hallucinations
- Memory impairment
- Bone fracture and bone marrow suppression
- Thoughts of suicide or self-harm
*All medications, including amitriptyline, can cause side effects that can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and understand the potential side effects and benefits of any medication.
Antidepressant Discontinuation
Antidepressant discontinuation syndrome, also known as antidepressant withdrawal, may occur after using amitriptyline for longer than three wells and then discontinuing abruptly instead of tapering gradually. The main symptoms are irritability, restlessness, and dream and sleep disturbance.1 Immediately get medical care if someone experiences headache, confusion, dizziness, or agitation.
Allergic Reactions to Amitriptyline
Amitriptyline has the potential to cause severe allergic reactions like rashes, hives, itching, peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing or talking, unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat, sun allergy, brown pigmentation (melanin), liver, joint, and blood abnormalities, which usually resolve after the drug discontinuation.6, 7 People allergic to other TCAs may be allergic to amitriptyline.
Allergic reactions to amitriptyline may include:1, 7
- Hives, raised patches of skin that are very itchy, blistered, or peeling
- High fever
- Flushing, which turns skin red and feels hot
- Swelling of the face, hands, feet, or throat
- Throat tightness, hoarse voice, wheezing, or trouble breathing
- Nausea, vomiting, belly pain
- Feeling lightheaded and fainting
- Pain and irritation of the pink, moist tissue that lines the eyes, mouth, vagina, and other organs.
- Very confused, drowsy, or dizzy
- A child appearing droopy or not responding normally
Tell your doctor or get medical help right away if you develop any of the symptoms listed above. For severe allergic reactions, you will be treated in a hospital to get your body back to normal with emergency drugs to calm your allergic response. If possible, your doctor might try to switch to a different antidepressant that is equally effective but less likely to cause the same allergic reaction.
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Amitriptyline Warnings & Precautions
Amitriptyline is not to be used by children under 12 years old. Some people can have suicidal thoughts when they first start taking the medication. Your doctor will monitor your progress during regular visits and alert your family or caregivers about the need to monitor your unusual behavior changes, agitation, and irritability.
Strictly avoid the drug if you have recently had a heart attack, are allergic to it, or have taken an MAO inhibitor ( isocarboxazid, linezolid, and phenelzine) within the past 14 days. Seek medical attention immediately if you experience life-threatening symptoms such as severe headache, dizziness, or loss of consciousness.
Precautions for taking amitriptyline include:1, 7
- Use during pregnancy and breastfeeding: Amitriptyline use during pregnancy is only beneficial if the potential benefit to the mother justifies the potential risk to the unborn baby. Use it carefully in nursing mothers as the drug passes into breast milk.
- Schizophrenia: Individuals may develop psychosis and exhibit extreme irrational fear or distrust of others. It is suggested to reduce the drug dose.
- Liver disease: Use the drug with caution as it is processed in the liver. Experts recommend lowering initial and maintenance doses by half, with cautious dose adjustments based on response and tolerability, with a maximum of 100 mg daily.
- Hemodialysis: Either avoid the drug or use it with caution during dialysis due to damaged kidneys. Monitoring is required for any heart-related abnormalities.
- Older adults: Older adults are at a higher risk of developing low blood pressure when standing suddenly (postural hypotension), constipation, difficulty urinating, dry mouth, blurry vision, and sedation. Lower doses are suggested with close monitoring.
- Surgery: Before any elective procedure, the recommendation is to gradually discontinue the drug due to interaction with anesthesia and irregular heart rhythm.
- Heart attack: Individuals who have recently had a heart attack should not take amitriptyline.1
- Photosensitization: Avoid sunlight exposure and tanning beds as they may cause intense sunburn. Always use sunscreen with a sun protection factor (SPF) of 30 or higher, and wear protective clothing outdoors.
Interactions With Amitriptyline
Taking multiple drugs and having underlying medical conditions can increase the risk of drug interactions. Generally, Amitriptyline is safe with most other drugs prescribed for your problem, but some drugs may affect (increase or decrease) its effectiveness.
The recommendation is to always consult your doctor before starting any new drug to avoid potential interactions. It is also important to avoid using complementary herbal remedies without discussing them with your doctor or pharmacist beforehand.
Following substances you should avoid while taking amitriptyline include:1, 7
- Topiramate: This is an anti-seizure medication. If taken with amitriptyline, topiramate may enhance its depressant effect by substantially increasing amitriptyline levels in the body.
- Anticholinergic drugs: These medications are used to treat Parkinson’s disease. Using medications such as glycopyrrolate and benztropine with amitriptyline may lead to temporary paralysis of the intestines due to weak muscle contractions.
- Antipsychotics (neuroleptic) drugs: These medications (Risperdal, Haldol) are used to treat symptoms of schizophrenia and bipolar disorder, such as hallucinations, delusions, and mania. Using amitriptyline with antipsychotics may cause a high fever.
- Cimetidine: This medication is used to reduce gastric acid. Using it with amitriptyline may elevate amitriptyline levels in the body and enhance the drug’s side effects, such as difficulty urinating, irregular heartbeat, and fainting.
- Selective serotonin reuptake inhibitors (SSRIs): SSRIs include medications such as Paxil, Lexapro, and Prozac. When SSRIs are taken with amitriptyline, the risk of serotonin syndrome or toxicity is increased. Serotonin syndrome can become a life-threatening condition
- Antiarrhythmic drugs: These medications are used to treat heart rhythm conditions. Using amitriptyline with medications like quinidine and flecainide can lead to heart problems (fast, irregular beats).
- Ethchlorvynol: Ethchlorvynol is a sedative used to treat insomnia. Using it with amitriptyline may increase dizziness, drowsiness, confusion, and difficulty concentrating. Older adults may experience impairment in thinking, judgment, and motor coordination.
Can You Overdose on Amitriptyline?
Amitriptyline overdose can be life-threatening when someone takes more than the prescribed amount or consumes substances that increase their concentration in the body. It can be accidental or intentional. The overdose symptoms develop rapidly, which is why immediate hospital monitoring is necessary to avoid the risk of death.1
The severity of the symptoms depends on factors such as the individual’s age, body weight, and current health condition. Overdose symptoms may include palpitations (arrhythmias), low blood pressure, confusion, drowsiness, muscle stiffness, vomiting, and low or high fever.
What Should You Do If You Take Too Much Amitriptyline?
Immediately seek medical help by calling 911, as amitriptyline overdose is dangerous, and individuals may pass out or have trouble breathing. If stable, contact the local poison control center (1-800-222-1222). It is crucial to provide drug details, like duration, frequency, and amount swallowed with or without food or other substances. Treatment is supportive care and drug absorption prevention by decontamination strategies, sufficient for the majority of overdosed individuals. Intentional overdose requires a psychiatric assessment before discharge.
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Amitriptyline Dosages for FDA-Approved Treatment
Amitriptyline is a drug approved by the FDA to treat depression in adults. Amitriptyline dosage may vary depending on factors including age, weight, and existing health conditions. It is available in the form of oral tablets with varying strengths of drug doses, typically ranging from 25 to 50 mg per day, to be taken at bedtime to avoid drowsiness during the day.
An FDA-approved drug is determined to provide benefits that outweigh its known and potential risks for the intended population.
Amitriptyline Forms & Strengths
Amitriptyline is available in oral tablet form with strengths ranging from 10 to 150 mg. Doctors typically start with a low dose and then gradually increase it based on the patient’s clinical response and tolerance. A typical daily dose ranges from 50 to 100 mg, either as a single dose or divided at bedtime.
Generally, it is safe to increase the dose by 25 to 50 mg per week until a daily dose of 150 to 300 mg is reached. In most cases, a daily dose of 75 mg, divided into multiple doses per day, is sufficient to achieve an improvement in symptoms. However, the sedative effect may be noticeable before the antidepressant effect, and it may take up to 30 days to achieve the desired outcome.
The maintenance dose is usually between 50 to 100 mg per day, although 40 mg per day is often adequate. It is best to take the total daily dose in a single dose at bedtime. To control symptoms, continue treatment with the lowest effective dose. It may take three months or longer to see a satisfactory improvement without recurring symptoms. For adolescents and elderly individuals, lower doses of 10 mg three times daily, with an additional 20 mg at bedtime, are often sufficient. However, individuals with liver disease should use amitriptyline with caution.
Amitriptyline is available in the following forms and strengths:1
- 10 milligrams (mg) oral tablet
- 25 milligrams (mg) oral tablet
- 50 milligrams (mg) oral tablet
- 75 milligrams (mg) oral tablet
- 100 milligrams (mg) oral tablet
- 150 milligrams (mg) oral tablet
For the best results, take the drug as advised by your doctor and follow all instructions closely. Remember to take it at bedtime if you are taking it once every day. Keep taking the drug even if you feel well.
How Should I Take Amitriptyline?
Take amitriptyline by mouth as directed by your doctor, usually 1 to 4 times daily. If you take it once a day, take it at bedtime to reduce daytime sleepiness. Follow all directions on your prescription and read drug instruction sheets carefully. Your doctor may sometimes change your dose, so use the drug exactly as directed. It may take up to 4 weeks before noticing an improvement in symptoms. If your symptoms do not improve, inform your doctor. To get the most benefit and help you remember, take this drug daily regularly at the same time.
If you require surgery, you may stop taking it for a short time. Do not stop using amitriptyline suddenly, or you may experience unpleasant withdrawal symptoms. Ask your doctor how to stop the drug safely. To reduce the risk of side effects like drowsiness, dry mouth, and dizziness, the doctor may direct you to start taking a low dose followed by a gradual increase. You may take it with or without meals.
What Happens If I Miss a Dose of Amitriptyline?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take two doses simultaneously to make up for a missed one. It is important not to stop taking the drug without consulting your doctor. Suddenly stopping this drug may worsen some medical conditions.
Questions to Ask Your Healthcare Provider About Amitriptyline (Elavil)
It is helpful to ask for all the necessary drug details, like its duration of use, potential side effects, drug interaction, and other relevant information. You must provide your complete medical history to your doctor, psychiatrist, and therapist. You may get a drug prescription online if you need to change prescribers. Many online psychiatry services are available to help individuals who prefer to discuss their health issues with specialists and manage their symptoms in the comfort and privacy of their homes.
Questions to ask your care team about amitriptyline include:
- How long will it take for me to adjust to taking amitriptyline?
- Am I at risk for more severe symptoms if I am already taking other anxiety /depression medications?
- What is the best dose to ensure fewer side effects?
- When should I reach out to you if I am experiencing sexual side effects?
- Is there anything I should tell my therapist about this new drug?
- Is it safe to take amitriptyline with my other drugs?
- Does my medical history indicate a need to adjust my dose?
- What should I do if I want to stop taking amitriptyline?
- How do I take amitriptyline?
- Can I increase the dose if no improvement?
- Are there any side effects of amitriptyline?
- What should I avoid during the amitriptyline treatment?
- What to do if I miss an amitriptyline dose?
- What happens If I overdose?
- Will I experience withdrawal effects after stopping it?
- Is it safe to use amitriptyline during pregnancy and breastfeeding?
In My Experience
In my experience, individuals treated with amitriptyline seem to recover better than those who take other alternative treatments. However, it is crucial to monitor closely for any potential side effects. Doctors must advise caregivers to keep a close watch and report any new or worsening symptoms.
Additional Resources
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