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Anxiety Medication: What FDA Has Approved

What Anxiety Medication Has FDA Approved, and What Do the Labels Warn About?

Anxiety medication falls into a few classes that NIMH describes: SSRI and SNRI antidepressants, benzodiazepines, buspirone, and beta-blockers, which are prescribed off-label. FDA labels approve specific medicines for specific conditions, such as escitalopram and duloxetine for generalized anxiety disorder, and antidepressants and benzodiazepines each carry a boxed warning. Only a prescriber can decide what fits you; if cost is a barrier, the low-cost care checker shows clinics that take Medicaid, Medicare or a sliding fee.

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Anxiety medication can help many people, and it’s an area where accuracy matters. Everything here comes from two places: the FDA-approved prescribing labels for each medicine, and the National Institute of Mental Health (NIMH). It explains what each class is, what FDA has approved it for, and what the labels warn about.

It won’t tell you which medicine is right for you. That depends on your health, your history and your other medicines, and only a prescriber can weigh those.

The Main Classes of Anxiety Medication

NIMH describes several kinds of medicine used for anxiety disorders. They work differently, take different amounts of time to help, and carry different warnings.

  • SSRIs and SNRIs. These antidepressants are often used for anxiety too. NIMH says that for panic disorder and social anxiety disorder, providers typically start with SSRIs or other antidepressants because they have fewer side effects than other options. NIMH says antidepressants usually take 4 to 8 weeks to work.
  • Benzodiazepines. These are sedative anti-anxiety medicines. NIMH says they can quickly reduce anxiety and are used for some short-term symptoms and sometimes for generalized anxiety disorder (GAD). Long-term use can lead to tolerance or dependence, so providers usually prescribe them for short periods and taper them slowly.
  • Buspirone. A different type of anti-anxiety medicine that can be used over longer periods. NIMH says it isn’t a sedative, has less potential to be addictive than benzodiazepines, and must be taken every day for 3 to 4 weeks to reach its full effect. It doesn’t work on an as-needed basis.
  • Beta-blockers. NIMH says providers may prescribe these off-label, meaning they aren’t approved for anxiety, to manage physical symptoms such as a racing heart, sweating and tremors. NIMH says they’re commonly the medicine of choice for the performance type of social anxiety. They generally aren’t recommended for people with asthma or diabetes.

What FDA Has Approved, Medicine by Medicine

Each FDA label lists the conditions the medicine is approved to treat. The table shows the anxiety-related approvals from current labels on DailyMed, the National Library of Medicine’s label database. Some of these medicines are also approved for depression or other conditions; those are left out of the table for clarity. The order is by class, not by any ranking.

Medicine (brand) Class Anxiety-related FDA approvals on the label Boxed warning
Escitalopram (Lexapro) SSRI Generalized anxiety disorder, adults and children 7 and older Suicidal thoughts and behaviors
Sertraline (Zoloft) SSRI OCD, panic disorder, PTSD, social anxiety disorder Suicidal thoughts and behaviors
Paroxetine (Paxil) SSRI OCD, panic disorder, social anxiety disorder, generalized anxiety disorder, PTSD, in adults Suicidal thoughts and behaviors
Fluoxetine (Prozac) SSRI OCD, panic disorder Suicidal thoughts and behaviors
Duloxetine (Cymbalta) SNRI Generalized anxiety disorder, adults and children 7 and older Suicidal thoughts and behaviors
Venlafaxine extended-release (Effexor XR) SNRI Generalized anxiety disorder, social anxiety disorder, panic disorder, in adults Suicidal thoughts and behaviors
Buspirone Anti-anxiety (non-benzodiazepine) Anxiety disorders and short-term relief of anxiety symptoms None on the label
Alprazolam (Xanax) Benzodiazepine Acute treatment of generalized anxiety disorder; panic disorder, in adults Opioid use; abuse, misuse and addiction; dependence and withdrawal
Clonazepam (Klonopin) Benzodiazepine Panic disorder Opioid use; abuse, misuse and addiction; dependence and withdrawal
Lorazepam (Ativan) Benzodiazepine Anxiety disorders and short-term relief of anxiety symptoms Opioid use; abuse, misuse and addiction; dependence and withdrawal

A few notes from the labels themselves:

  • The Paxil and Effexor XR labels say these medicines are not approved for use in children.
  • The Ativan label says anxiety or tension from the stress of everyday life usually doesn’t call for an anti-anxiety medicine, and that its effectiveness beyond 4 months hasn’t been assessed in systematic clinical studies.
  • The buspirone label says it is not chemically related to benzodiazepines and is not a controlled substance.

Labels change. For the current version of any label, search the medicine on DailyMed or ask your pharmacist for the Medication Guide.

The Antidepressant Boxed Warning

Every SSRI and SNRI label in the table carries FDA’s strongest warning, a boxed warning. It says antidepressants increased the risk of suicidal thoughts and behaviors in children, teens and young adults in short-term studies. The Prozac and Cymbalta labels add that the studies didn’t show an increase over age 24, and showed a reduction at 65 and older.

The labels say anyone starting an antidepressant, at any age, should be watched closely for worsening mood or suicidal thoughts. NIMH adds that the risk is highest in the first few weeks after starting or after a dose change. Families and caregivers are advised to stay in close touch with the prescriber.

If you or someone you care for has new or worse suicidal thoughts, call the prescriber right away. In a crisis, call or text 988, or chat at 988lifeline.org, any time. Veterans can dial 988 and press 1. If someone is in immediate danger, call 911.

The Benzodiazepine Boxed Warning

In 2020, FDA required a stronger boxed warning on every benzodiazepine. The labels for Xanax, Klonopin and Ativan now warn about three risks:

  • Use with opioids. Taking benzodiazepines with opioids may cause profound sedation, slowed breathing, coma and death.
  • Abuse, misuse and addiction, which can lead to overdose or death. Misuse often involves alcohol or other drugs, which raises the risk of serious harm.
  • Dependence and withdrawal. Continued use can lead to physical dependence. Stopping suddenly or cutting the dose quickly after continued use can cause withdrawal reactions that can be life-threatening.

FDA’s advice to patients is direct: don’t suddenly stop taking a benzodiazepine without first making a plan with your health care professional to lower the dose slowly. If you’re worried about your own use of a benzodiazepine or another substance, the sister site rehab.help covers treatment for substance use.

Side Effects and Safety Basics

NIMH lists upset stomach, headache and sexual problems as common side effects of SSRIs and other antidepressants, and says they’re generally mild and tend to fade with time. NIMH also warns about serotonin syndrome, a rare but life-threatening reaction that can happen when antidepressants are combined with other medicines or supplements that act on serotonin, such as certain migraine drugs or St. John’s wort.

NIMH’s safety checklist for any prescription:

  • Tell your provider about every medicine, vitamin and supplement you take.
  • Mention allergies and any past problems with medicines.
  • Make sure you understand how to take the medicine before you start.
  • Never take medicine prescribed for someone else.
  • Call your provider right away if a medicine seems to be doing more harm than good.

NIMH says people should not stop a prescribed medicine, even when they feel better, without a health care provider’s help. You can report serious side effects to FDA MedWatch online or at 1-800-332-1088.

Medication and Therapy Together

NIMH says treatment for anxiety disorders typically involves psychotherapy, medication or both. Psychotherapy can be used instead of medicine or alongside it, and NIMH notes that even when medicine relieves symptoms, therapy can help with the fears and thinking patterns behind them. Cognitive behavioral therapy is the most studied option; the CBT guide and the anxiety therapy guide explain how it works. For OCD, the OCD therapist guide covers exposure and response prevention.

Who Prescribes, and How to See Someone

NIMH suggests starting with your primary care provider, who can check for physical causes and refer you on. Psychiatrists are medical doctors who focus on mental health, including medicines. Medicare lists psychiatrists, nurse practitioners and physician assistants among the providers it covers for medication management. The psychiatrist vs therapist guide explains the differences.

To find a clinic that offers psychiatric care, use the mental health care finder. SAMHSA lists 1,479 community mental health centers, a common place to start for public and low-cost care.

Paying for Anxiety Medication

  • Generics. FDA says a generic has the same active ingredient, strength and form as the brand-name drug and works the same way, with the same benefits and risks. Ask your prescriber or pharmacist whether a generic version of your medicine is available.
  • Medicaid. Medicaid.gov says all states currently cover outpatient prescription drugs for Medicaid enrollees. SAMHSA lists 10,558 facilities that accept Medicaid. See the Medicaid therapy guide.
  • Medicare. Part B covers visits for psychiatric evaluation and medication management, and Part D helps pay for brand-name and generic prescriptions. Medicare’s Extra Help program lowers Part D costs for people with limited income and resources. See the Medicare therapy guide.
  • Insurance. Marketplace and job-based plans must follow mental health parity rules; the insurance coverage guide explains them.
  • No insurance. SAMHSA lists 5,770 facilities with a sliding fee or payment help. The free mental health care guide and the low-cost care checker can help you find one near you.

Frequently Asked Questions

How Long Does Anxiety Medication Take to Work?

It depends on the class. NIMH says antidepressants usually take 4 to 8 weeks to work, and buspirone must be taken every day for 3 to 4 weeks to reach its full effect. NIMH describes benzodiazepines as working quickly, which is why they're used for short-term symptoms.

Is There an Over-the-Counter Medicine for Anxiety?

Every medicine in this guide's table is a prescription drug. NIMH notes that FDA has not approved any natural product for treating depression, and that supplements such as St. John's wort can interact with prescription medicines. Talk to a health care provider before trying any supplement.

Can I Stop Anxiety Medication When I Feel Better?

Not on your own. NIMH says people shouldn't stop a prescribed medication, even when feeling better, without a health care provider, who can lower the dose slowly. FDA warns that stopping a benzodiazepine suddenly after continued use can cause withdrawal reactions that can be life-threatening.

Who Can Prescribe Anxiety Medication?

Psychiatrists, primary care doctors and other licensed prescribers such as nurse practitioners. Medicare lists psychiatrists, nurse practitioners and physician assistants among the providers who can give mental health services, including medication management. The psychiatrist vs therapist guide explains who does what.

Are Generic Anxiety Medicines the Same as Brand Names?

FDA says a generic has the same active ingredient, strength, dosage form and route as the brand-name drug, and works the same way with the same benefits and risks. Ask your prescriber or pharmacist whether a generic is available.

Are Beta-Blockers Approved for Anxiety?

No. NIMH says providers may prescribe beta-blockers off-label for short-term anxiety symptoms such as a racing heart, sweating and tremors, even though they aren't approved for that purpose. NIMH adds that they generally aren't recommended for people with asthma or diabetes.

More on Getting Started

This guide explains mental health care in plain language from official sources. It isn't medical advice; a licensed clinician can assess what care fits your situation.

Sources

  1. NIMH: Mental Health Medications
  2. NIMH: Generalized Anxiety Disorder: What You Need to Know
  3. NIMH: Panic Disorder: What You Need to Know
  4. NIMH: Social Anxiety Disorder: What You Need to Know
  5. FDA label (DailyMed): Lexapro (escitalopram)
  6. FDA label (DailyMed): Zoloft (sertraline)
  7. FDA label (DailyMed): Paxil (paroxetine)
  8. FDA label (DailyMed): Prozac (fluoxetine)
  9. FDA label (DailyMed): Cymbalta (duloxetine)
  10. FDA label (DailyMed): Effexor XR (venlafaxine extended-release)
  11. FDA label (DailyMed): buspirone hydrochloride tablets
  12. FDA label (DailyMed): Xanax (alprazolam)
  13. FDA label (DailyMed): Klonopin (clonazepam)
  14. FDA label (DailyMed): Ativan (lorazepam) tablets
  15. FDA: Boxed Warning Updated for Benzodiazepine Drug Class (2020)
  16. FDA: Generic Drug Facts
  17. NIMH: Depression
  18. Medicaid.gov: Prescription Drugs
  19. Medicare.gov: Help With Drug Costs
  20. Medicare.gov: Mental Health Care (Outpatient)

In crisis? Call or text 988 or chat at 988lifeline.org, any time. If someone is in immediate danger, call 911. anxiety.help is an independent guide, not a mental health provider or crisis service, and doesn't give medical advice. For a free, confidential referral, call SAMHSA's National Helpline at 1-800-662-4357.