Key Takeaways From the Recent FDA-Funded Benzodiazepine Tapering Guideline

Benzodiazepines, often called “benzos,” are a class of sedative, hypnotic medications (see Table, below, for a list of oral formulations of these drugs). The Food and Drug Administration (FDA) approved these medications to treat, depending on the specific drug, conditions such as alcohol withdrawal, anxiety disorders, primary insomnia and seizures. As of 2023 approximately 24 million Americans reported using a benzodiazepine.

Benzodiazepine labels include boxed warnings (the strongest warnings the FDA can require) highlighting their serious risks, including abuse, addiction and overdose, which can be deadly, especially if these drugs are used concomitantly with alcohol, opioids or illicit substances.[1] The boxed warnings also include the risk of physical dependence, a state of repeatedly taking these drugs and experiencing unpleasant withdrawal symptoms if they are stopped.

Due to these risks, Public Citizen’s Health Research Group has long designated all benzodiazepines as Do Not Use for insomnia, anxiety or any other uses, except for alprazo-lam (XANAX, XANAX XR and generics), which we designated as Do Not Use Except For Panic Disorder, and clonazepam (KLONOPIN and generics), which the FDA approved only for certain types of seizures and panic disorder.[2]

Unfortunately, many patients take benzodiazepines for extended periods to treat conditions that can be managed with lower-risk therapies. Safe deprescribing of benzodiaze-pines can be challenging because rapid dosage reductions may cause acute, potentially life-threatening withdrawal reactions, including abdominal cramps, aggression, agitation, anxiety or panic attacks, chest pain, confusion, depression or dysphoria (unease or dissatisfaction), headache, insomnia or hypersomnia, irritability, muscle pain or twitches, nausea or vomiting, poor memory or reduced concentration, and rapid heartbeat. In addition, tapering (gradual dose reduction) of benzodiazepines may be complicated by rebound reactions (recurrence of the signs and symptoms for which benzodiazepines were originally prescribed).

A recent FDA-funded clinical practice guideline offers helpful evidence- and consensus-based strategies for clinicians to determine whether tapering benzodiazepines may be appropriate for patients and, if so, how to taper them.[3] The guideline was a joint effort by the American Society of Addiction Medicine and nine other U.S. medical and professional societies; it was published online in June 2025 in the Journal of General Internal Medicine.

Table. List of FDA-Approved Oral Benzodiazepines*[4]

*All are designated by Worst Pills, Best Pills News as Do Not Use except for alprazolam (which is designated Do Not Use Except For Panic Disorder) and clonazepam (which is approved only for certain types of seizures and panic disorder).
†Combination with another drug

Key recommendations[5]

The guideline applies to adults who have been taking benzodiazepines regularly and may be at risk of physical dependence. It does not apply to patients taking these drugs for end-of-life or palliative care.

Although many patients who have been taking benzodiazepines for less than four weeks can discontinue them without a taper, some may experience significant withdrawal reactions, according to the guideline. Similarly, some patients who have been taking low doses of these drugs for six weeks may not be physically dependent on them.

However, the risk of physical dependence is high for patients taking benzodiazepines at least four days a week for three months or longer. Therefore, benzodiazepines should be tapered rather than suddenly discontinued in patients at high risk of developing withdrawal reactions.

Generally, the guideline strongly recommends that clinicians should consider dose reductions of 5% to 10% for initial benzodiazepine tapering without increasing the pace of tapering by more than 25% every two weeks.

For patients at great risk of physical dependence (such as those who have been taking high benzodiazepine doses for more than a year), the guideline recommends a slower tapering schedule. Specifically, only a 5% dose reduction can be considered for the initial reduction and 5% to 10% every six to eight weeks (or even slower, as needed) for further reductions.

The guideline emphasizes that clinicians should develop individualized tapering plans with each patient through shared decision-making. It strongly recommends that clinicians should evaluate the response of each patient to every benzodiazepine dose reduction and adjust their tapering schedule accordingly.

The guideline also recommends that clinicians should incorporate adjunctive psychosocial interventions (such as cognitive behavioral therapy and peer support) when needed to support patients during the tapering process. Generally, clinicians should avoid reinstating benzodiazepines; instead, they should consider prescribing non-benzodiazepine medications for patients who are unable to tolerate benzodiazepine withdrawal reactions. Overall, it may take months to years to completely taper off benzodiazepines in patients who have been taking high doses of these drugs for a long time.

It is especially important for clinicians to educate patients with protracted withdrawal reactions about the cause of their symptoms and reassure them that they are likely to resolve with time as their brains adjust to the lack of benzodiazepine. Importantly, clinicians should use harm-reduction strategies, such as providing opioid overdose reversal drugs (including naloxone [NARCAN, REXTOVY, RIVIVE and generics]) to patients who are concomitantly taking opioids or are at risk of opioid overdose.

What You Can Do

Due to their serious risks, it is best not to start taking benzodiazepines, except alprazolam (for panic attacks) and clonazepam (for panic attacks or seizures) if there is no other effective treatment option. If you are currently taking a benzodiazepine on a regular basis, try to develop a schedule with your doctor to gradually taper your dose safely.
 

References

[1] Waylis Therapeutics LLC. Label: diazepam (VALIUM). March 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/013263Orig1s101lbl.pdf. Accessed September 2, 2025.

[2] FDA belatedly requires abuse-related black-box warnings for benzodiazepines. Worst Pills, Best Pills News. May 2021. https://www.worstpills.org/newsletters/view/1399. Accessed September 2, 2025.

[3] Brunner E, Chen C-YA, Klein T, et al. Joint clinical practice guideline on benzodiazepine tapering: considerations When risks outweigh benefits. J Gen Intern Med. doi:10.1007/s11606-025-09499-2. Published online ahead of print June 17, 2025.

[4] Food and Drug Administration. FDA drug safety communication: FDA requiring boxed warning updated to improve safe use of benzodiazepine drug class Includes potential for abuse, addiction, and other serious risks. September 23, 2020. https://www.fda.gov/media/142368/download. Accessed August 26, 2025.

[5] Brunner E, Chen C-YA, Klein T, et al. Joint clinical practice guideline on benzodiazepine tapering: considerations When risks outweigh benefits. J Gen Intern Med. doi:10.1007/s11606-025-09499-2. Published online ahead of print June 17, 2025.