Mirtazapine, better known by its brand name Remeron, is an antidepressant medication that is FDA-approved for the treatment of major depressive disorder (MDD) and used off-label for conditions like anxiety, PTSD, panic disorder, social anxiety disorder, fibromyalgia, and insomnia. [1] Due to its sedative effects, the potential for abuse and addiction may come to mind, which may prompt individuals to question if mirtazapine is a controlled substance.
Unlike benzodiazepines or opioids, mirtazapine is not classified as a controlled substance in the United States. However, this doesn’t mean taking mirtazapine doesn’t come with potential risks or the ability to be habit-forming or be abused.
Below, we will discuss what mirtazapine is, its common uses, why it’s not a controlled substance, and its potential for misuse.
- Mirtazapine is not a controlled substance because it has a low potential for abuse and dependence.
- Although it is not considered highly addictive, abrupt discontinuation can lead to withdrawal symptoms.
- Mirtazapine is primarily prescribed for depression but is also used off-label for anxiety, insomnia, and PTSD.
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Is mirtazapine a controlled substance?
Mirtazapine is not classified as a controlled substance by the Drug Enforcement Administration (DEA) due to their determination that it has an extremely low potential for addiction or abuse. [1]
Controlled substances are drugs for which make, use, handling, storage, and distribution are tightly controlled by the government due to their potential for abuse or dependence. They are categorized into schedule I-V based on their abuse potential, with schedule I drugs having the highest abuse potential and no medical uses or treatments, and V having the lowest abuse potential and an accepted medical use. [2]
Mirtazapine (Remeron) and its uses
Mirtazapine belongs to a class of antidepressants known as tetracyclic antidepressants (TeCA) or noradrenergic and specific serotonergic antidepressants (NaSSAs). These medications work by increasing serotonin and norepinephrine release in the brain by blocking specific serotonin and norepinephrine receptors, unlike SSRIs, which increase serotonin levels by blocking its reuptake. [3]
Mirtazapine is FDA-approved for the treatment of major depressive disorder (MDD). It has also been studied and prescribed off-label for the treatment of:
- Anxiety disorders (generalized anxiety disorder, obsessive compulsive disorder, social anxiety disorder, and panic disorder) [3]
- Post-traumatic stress disorder
- Insomnia and obstructive sleep apnea [3]
- Appetite stimulation
- Nausea and vomiting
- Fibromyalgia
- Movement disorders
- Headaches
Research has also demonstrated it may have positive effects on substance abuse disorders. In individuals with alcohol use disorder, it has been shown to reduce social anxiety, general anxiety, and depressive symptoms. In those recovering from methamphetamine use disorder, it can result in decreased methamphetamine use, decreased sexual risk behaviors, and reduced withdrawal symptoms. [3]
Implications and abuse potential
While mirtazapine is not a controlled substance, it can still be misused or abused. Individuals sometimes take the medication at higher doses for its sedative and calming effects, although such cases are rare. This is because, unlike opioids or stimulants, researchers have found that mirtazapine does not cause a “high” or extreme euphoria, making its abuse potential much lower. [1]
However, some research suggests that mirtazapine does have some abuse potential. A study on mice found that mirtazapine can induce drug-seeking behavior, cognitive impairment, and withdrawal symptoms similar to those seen with addictive substances. Mice given mirtazapine at higher concentrations preferred it over water and showed signs of withdrawal after abstinence, including increased immobility in forced swimming and tail suspension tests. This suggests that while mirtazapine is not classified as a controlled substance, it may still carry a risk of dependence and withdrawal in some cases. [4]
Further research is needed to fully understand its potential for misuse.
Safe use and guidelines for prescribing mirtazapine
To minimize risks, mirtazapine should only be used as prescribed. It is available in various dosages, including 7.5 mg, 15 mg, 30 mg, and 45 mg oral tablets and 15 mg, 30 mg, and 45 mg oral disintegrating tablets.
It is recommended to start at a low dose (typically 15 mg) and increase the dosage as needed. According to research, between 15 mg and 45 mg is often sufficient for treating MDD. [1]
It is best to take it before bedtime due to its sedating effects. It is also important not to mix mirtazapine with alcohol or other sedatives like benzodiazepines, which can intensify drowsiness.
Suddenly stopping mirtazapine could cause discontinuation syndrome, which can cause depression, panic attacks, tinnitus, restlessness, insomnia, decreased appetite, or nausea and vomiting. This is why it is recommended to slowly taper off the medication under medical supervision to avoid withdrawal symptoms. Your doctor will likely have you taper off the medication over a period of 2 to 3 weeks, depending on how long you were on the medication and your dosage. If you have a history of withdrawal symptoms, a slower taper is often ideal. [1]
Always follow your prescriber's directions on what dosage to take, when to take the medication, and how to stop the medication if you both decide this is appropriate.
