The time has come for over-the-counter antidepressants

Anyone can now walk into a pharmacy in the United States and buy oral contraceptives over the counter without a prescription, thanks to the FDA’s approval of norgestrel (Opill). This change reflects the drug’s safety and the public health imperative to ensure wider access to birth control. But another safe class of medicine that addresses a massive public health need remains unavailable except by prescription: the antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

These medications, which have been used in the U.S. for three decades, have repeatedly been shown to be safe and effective for treating major depression and anxiety disorders.

The need for accessible depression treatment has never been greater. Multiple national surveys, including one I help lead, report high levels of depression. More than 1 in 10 adults in a U.S. Census survey reported needing therapy for mental health, and being unable to get it — including 1 in 4 who reported current depression or anxiety.

Access to psychiatrists is extremely limited in many areas of the U.S.: long wait times make a mockery of the 2008 mental health parity mandate. That means the vast majority of antidepressants are prescribed by non-psychiatrists, particularly primary care physicians. Yet many primary care practices struggle to provide the same kind of care for depression that they provide for other chronic illnesses. After the Covid-19 pandemic, even access to primary care can be hit or miss.

People with depression may be uncomfortable talking about their symptoms, or simply unable to schedule and keep appointments because of work or family obligations. Depression itself can make it harder to plan and follow through. Telehealth can fill the gap, but the quality of this care is difficult to measure. And these visits add cost to what could otherwise be inexpensive treatment, without any demonstrated improvement in safety.

Food and Drug Administration policy states that non-prescription medications must meet three criteria: they can be used for self-diagnosed conditions; there’s no need for a clinician’s involvement to be used safely; and they have a low potential for misuse and abuse.

In reality, many OTC products treat symptoms or rely on consumers to diagnose themselves — think yeast infections, acid reflux, or respiratory infections. In the case of major depression or generalized anxiety, screening surveys have been developed for primary care that could help people determine their likely diagnosis with at least the degree of confidence of many OTC applications.

What about use or misuse? Depression is associated with increased risk for suicide, and medication overdose is among the most common methods of suicide. But walk through the aisles at your local pharmacy and pick any given medicine off the shelf: the odds are good it is more dangerous in overdose than an SSRI. Fatal overdoses are far more likely to involve drugs other than antidepressants.

Among people age 25 and older, there is clear evidence that taking antidepressants does not increase the risk for suicide — in fact, the risk of suicidal thoughts or acts is reduced in this group, particularly among those 65 and older. For those younger than 25, the risk for suicidal behaviors or thoughts in clinical trials was modestly greater than that of placebo. So buying SSRIs over the counter could be restricted to people 25 and older, at least at first, just as some states restrict OTC pseudoephedrine (Sudafed) purchases to people age 18 or older.

Another objection to over-the-counter SSRIs is that not everyone believes in pills for depression. Some still question the biological basis of this disorder, despite the identification of more than 100 genes that increase depression risk and neuroimaging studies showing differences in the brains of people with depression.

To be sure, there are alternatives to pills. Certain talk therapies, like cognitive behavioral therapy, can be as effective as antidepressants, and some people prefer talking with a therapist to taking a medicine. But not everyone: weekly visits for eight to 12 sessions or more can entail substantial time and money. Here too, access to psychotherapists is a massive problem, particularly for individuals who seek to use insurance, or have none.

No treatment works for everyone, but around one in three people with depression get well with an initial antidepressant medication. Allowing over-the-counter access is not a panacea, but could open the door to a safe, effective, and inexpensive treatment for many who need it.

What’s needed to make this happen? An SSRI manufacturer with the courage to engage with the FDA and invest the necessary resources for a prescription-to-OTC switch, a well-trod path that has previously included medicines for allergies, acid reflux, and emergency contraception, among others. This process would primarily involve studies to prove that consumers can understand and follow the medication label, not new clinical trials, because more than three decades of evidence shows that SSRI antidepressants are safe and effective.

Mental health is a public health crisis in the United States, with access to evidence-based treatment a huge challenge. With part of the solution hiding in plain sight, it’s time to do everything possible to give Americans another way to get treatment.

Roy Perlis is a psychiatrist and associate chief for research in the Department of Psychiatry at Massachusetts General Hospital in Boston, and a professor of psychiatry at Harvard Medical School.

If you or someone you know may be considering suicide, contact the 988 Suicide & Crisis Lifeline: call or text 988 or chat 988lifeline.org. For TTY users: Use your preferred relay service or dial 711 then 988.