Non-Benzodiazepine Anxiety Medications: Labeled and Off-Label Uses

Labeled for anxiety and off-label: the difference

A labeled use is one FDA has approved and that appears in the medicine's prescribing information. Off-label means a clinician prescribes it for something else. You should know when it applies, because the medicine has not been through FDA approval for that use.

Medicines here are grouped by that difference. This is not a ranking. A medicine appearing first does not make it the right one for you.

Buspirone: labeled for anxiety

The buspirone label lists the management of anxiety disorders and the short-term relief of anxiety symptoms. The label says its mechanism is unknown and that it is not chemically or pharmacologically related to benzodiazepines.

NIMH says buspirone can be used over longer periods, must be taken every day for 3 to 4 weeks to reach its full effect, and does not work on an as-needed basis. The label says it lacks the prominent sedative effect of more typical anti-anxiety medicines, and that in human and animal studies it showed no potential for abuse and no evidence of tolerance or dependence.

Commonly observed side effects on the label include dizziness, nausea, headache, nervousness, lightheadedness and excitement. The label says buspirone must not be used with MAOIs intended to treat depression, or within 14 days of them, because of serotonin syndrome or elevated blood pressure risk. It also warns that buspirone will not block withdrawal from benzodiazepines, so a person coming off a benzodiazepine should not treat it as a replacement without medical advice.

Hydroxyzine: labeled for anxiety and tension

Hydroxyzine's label lists symptomatic relief of anxiety and tension associated with psychoneurosis, an older medical term, and it has other labeled uses such as itching from certain allergic conditions. The same label says its effectiveness as an anti-anxiety medicine for long-term use, more than 4 months, has not been assessed by systematic clinical studies.

Important warnings: it is contraindicated in people with a prolonged QT interval, a finding on a heart tracing, and the label reports QT prolongation and a serious heart rhythm problem after marketing. It can also add to the effects of other medicines that slow the nervous system. Reported side effects include dry mouth and drowsiness, and the label cautions against driving or operating dangerous machinery while taking it.

Propranolol: off-label for anxiety

Propranolol is a beta-blocker. The National Institute of Mental Health (NIMH) says providers may prescribe beta-blockers off-label for short-term anxiety symptoms, even though they are not approved for that purpose. It explains that they can help manage physical symptoms such as rapid heart rate, sweating and tremors, for instance in phobias.

NIMH says beta-blockers generally are not recommended for people with asthma or diabetes because they may worsen symptoms of both. Please do not stop any beta-blocker without talking to your prescriber. Our propranolol page goes through its label and warnings in more detail.

Gabapentin: off-label for anxiety

The Neurontin (gabapentin) label lists postherpetic neuralgia, a nerve pain that can follow shingles, and add-on treatment for partial-onset seizures. Anxiety is not on the label. A 2020 review of anxiety treatments says gabapentin has been prescribed off-label for anxiety despite a lack of research evidence supporting that use.

The label warns about serious allergic reactions, drowsiness and dizziness that can affect driving, suicidal thoughts and behavior, and slowed breathing, especially with opioids or other sedating medicines or with existing breathing problems. It says the dose should be reduced gradually over at least a week, since suddenly stopping can raise the risk of seizures and withdrawal symptoms. The label says gabapentin is not a controlled substance, and the review adds that scheduling may vary between states.

Pregabalin: not FDA-approved for anxiety

The Lyrica (pregabalin) label lists nerve pain from diabetes, postherpetic neuralgia, add-on treatment for partial-onset seizures, and fibromyalgia, among other uses. Anxiety is not listed. The same review says pregabalin is approved for generalized anxiety disorder in the European Union but not by the FDA, and that the US application for that use was withdrawn in 2010.

Most common side effects on the label include dizziness, sleepiness, dry mouth, swelling, blurred vision, weight gain and trouble concentrating. Warnings cover swelling of the face, mouth and neck that can be life-threatening, suicidal thoughts and behavior, and slowed breathing. The label says to reduce it gradually over at least a week. Pregabalin is a Schedule V controlled substance.

As of November 2026, a temporary federal rule (Federal Register, Fourth Temporary Extension) allows DEA-registered practitioners to prescribe Schedule II to V medicines by audio-video telemedicine without a prior in-person evaluation, under set conditions, through December 31, 2026. Rules may change after that date. Our guide on controlled medicines prescribed online explains more.

How we can help

Choosing between medicines depends on your diagnosis, health history and other medicines. A licensed psychiatrist on our team treats anxiety by secure video for people physically located in Pennsylvania or New York during each visit. Whether any of these is an option for you is a decision for you and your prescriber. Ask us whether our psychiatrist can help: contact us about medication care, read about online anxiety treatment, or see pages for buspirone and hydroxyzine.

If you are in crisis, call or text 988, or call 911. Locascio Wellness does not provide emergency services.