Cymbalta (Duloxetine) Controlled Substance Status

Natalie Watkins
Dr. Jennie Stanford
Written by Natalie Watkins on 26 February 2025
Medically reviewed by Dr. Jennie Stanford on 05 March 2025

Cymbalta is the brand name for the drug duloxetine. It is a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant used to treat many forms of anxiety and major depressive disorder (MDD). It is also used to relieve pain in patients with fibromyalgia, chronic pain, and neuropathic pain.

Cymbalta isn’t on the list of controlled substances, but it is a prescription-only drug. Here’s everything you need to know.

Key takeaways:
  • Cymbalta (duloxetine) is an antidepressant, and it can also be used to treat chronic pain.
  • It is not a controlled substance according to the Controlled Substances Act because it has a very low potential for misuse.
  • Cymbalta can cause withdrawal symptoms. Dosages should be reduced gradually before stopping taking it.
a photo of a Cymbalta box and a blister pack of duloxetine pills on a white background

Is Cymbalta a controlled substance?

The Controlled Substances Act lists some substances and drugs that are subject to special controls around their use, storage, and distribution. The substances are listed in different schedules based on their risk of being misused. They impact the nervous system, creating effects such as euphoria, and they may cause physical and psychological dependence.

Cymbalta does work on the central nervous system, but it is slow to take effect and does not create a high in the same way other drugs may. As a result, it is not considered to be at risk of being misused.

Although Cymbalta is not a controlled substance, it is still a prescription-only medication. You are not able to buy it over-the-counter, and you should only use Cymbalta which has been prescribed for you by a clinician.

What is duloxetine and what is it used for?

Duloxetine is an antidepressant that is approved by the FDA to treat chronic pain, fibromyalgia, neuropathic pain (pain that comes from the nerves), anxiety, and depression. It can also sometimes be used off-label to treat stress urinary incontinence (SUI).

Cymbalta drug class

Cymbalta is a serotonin and norepinephrine reuptake inhibitor (SNRI). This means that it increases how much serotonin and norepinephrine are found in the brain, which can help treat symptoms of depression and other conditions.

Cymbalta's potential for misuse and dependence

Because Cymbalta does not offer a euphoric high or other experience that makes it prone to abuse. It also takes effect over a period of weeks, rather than minutes or hours, which again reduces the probability of it being misused.

Coming off of Cymbalta can be difficult. It’s important to taper the dose. You may still get withdrawal symptoms, including dizziness, headache, vomiting, insomnia, the sensation of electric shocks, and fatigue. Rather than withdrawal, this is sometimes called a “discontinuation syndrome,” which can last for weeks or even longer.

Prescribing and usage guidelines

Cymbalta is typically taken once or twice per day as an oral tablet or capsule. A typical starting dose is 60 mg per day, although some patients will start at a lower dose of 30 mg per day. The total daily dosage rarely exceeds 120 mg per day.

Cymbalta should be taken without chewing or crushing the tablet or opening the capsule. Missed doses should be taken as soon as they are remembered unless it is nearly time for the next dose. Do not take two doses at the same time.

Cymbalta should usually not be stopped abruptly unless there is a pressing medical need to do so. The dosage should be gradually tapered under the guidance of a medical professional to minimize any unpleasant symptoms.

Any information here is offered as general information only and should not be taken as medical advice. Cymbalta should only ever be taken as prescribed by your doctor.

Side effects of Cymbalta

Common side effects of Cymbalta include:

  • Nausea
  • Headache
  • Dry mouth
  • Drowsiness
  • Fatigue
  • Insomnia
  • Constipation
  • Dizziness
  • Diarrhea

Other side effects can include heart palpitations, sexual dysfunction, anxiety, and hyperhidrosis (excessive sweating).

This is not an exhaustive list of the possible side effects of Cymbalta. Any side effects or possible adverse effects should always be discussed with your doctor or medical practitioner.

FAQs

Common questions about Cymbalta

Why is Cymbalta not listed under the Controlled Substances Act?

Cymbalta is not listed under the Controlled Substances Act because it is not considered to have the potential for abuse. It takes a relatively long time to take effect, does not give feelings of euphoria, and is unlikely to be taken recreationally.

Can Cymbalta cause dependence or withdrawal symptoms?

Cymbalta can cause unpleasant withdrawal symptoms, including dizziness, headache, and paresthesias (tingling sensations that can feel like electric shocks). Most people taking Cymbalta will reduce the dosage gradually to reduce these symptoms.

Is Cymbalta safe? What are its side effects?

Cymbalta is approved by the FDA, which means that it is considered both safe and effective, but it can cause side effects. The most common side effects caused by Cymbalta include nausea, dry mouth, and constipation. Rare but serious side effects include liver failure, serotonin syndrome, and manic episodes in patients with bipolar disorder.

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Resources:

  1. Food and Drug Administration. (n.d.). Cymbalta. Accessed February 23, 2025 from
  2. Bykov, K., He, M., & Gagne, J. J. (2020). Trends in Utilization of Prescribed Controlled Substances in US Commercially Insured Adults, 2004-2019. JAMA internal medicine, 180(7), 1006–1008.
  3. Lunn, M. P., Hughes, R. A., & Wiffen, P. J. (2014). Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia. The Cochrane database of systematic reviews, 2014(1), CD007115.
  4. Rodrigues-Amorim, D., Olivares, J. M., Spuch, C., & Rivera-Baltanás, T. (2020). A systematic review of efficacy, safety, and tolerability of duloxetine. Frontiers in Psychiatry, 11(1).
  5. Lisinski, A., Hieronymus, F., Näslund, J., Nilsson, S., & Eriksson, E. (2020). Item-based analysis of the effects of duloxetine in depression: a patient-level post hoc study. Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 45(3), 553–560.
  6. Williamson, O. D., Schroer, M., Ruff, D. D., Ahl, J., Margherita, A., Sagman, D., & Wohlreich, M. M. (2014). Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clinical therapeutics, 36(4), 544–551.
  7. Hirase, T., Hirase, J., Ling, J., Kuo, P. H., Hernandez, G. A., Giwa, K., & Marco, R. (2021). Duloxetine for the Treatment of Chronic Low Back Pain: A Systematic Review of Randomized Placebo-Controlled Trials. Cureus, 13(5), e15169.

Activity History - Last updated: 05 March 2025, Published date:


Reviewer

Dr. Jennie Stanford

MD, FAAFP, DipABOM

Jennie Stanford, MD, FAAFP, DipABOM is a dual board-certified physician in both family medicine and obesity medicine. She has a wide range of clinical experiences, ranging from years of traditional clinic practice to hospitalist care to performing peer quality review to ensure optimal patient care.

Activity History - Medically Reviewed on 26 February 2025 and last checked on 05 March 2025

Medically reviewed by
Dr. Jennie Stanford

Dr. Jennie Stanford

MD, FAAFP, DipABOM

Reviewer

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