Benzodiazepines come in many different dosages and strengths. One might assume there are enough dosages available to safely taper off of the drug but, for many patients, this is not true.  Breaking a pill in half, or even quarters, while tapering can result in severe and debilitating withdrawal symptoms, failed cessation, patient injury, seizures, psychosis, suicide, and/or death.  This could be easily prevented for many by making benzodiazepines available in smaller doses.

 FDA Prescribing Information Is Insufficient

0.25 mg of Generic Xanax (Alprazolam)

Xanax will be used to illustrate this problem, but the same concerns can be applied to all benzodiazepines. FDA Xanax prescribing literature states:

It is suggested that the dose be reduced by no more than 0.5 mg every three days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.  

Not only are these suggestions incredibly fast anecdotally among people who have actually attempted benzodiazepine tapers, but they also contradict other guidelines on benzodiazepine withdrawal issued by bodies such as the New York City Department of Health and Mental Hygiene, the State of Pennsylvania, the United States Veterans Administration, Government of South Australia and the National Pain Centre of Canada.  Also, the FDA’s Prescribing Information for Xanax does not quantify how many patients are resistant to all discontinuation regimens, what “resistant” entails, how many of those studied required an even more gradual discontinuation, or which alternative regimens were attempted before labeling a patient resistant.  The FDA literature additionally states that studies beyond 4 months of patient usage have not yet been conducted, and many of the benzodiazepine-dependent patients in question fall into that category.

According to the American Psychiatric Association’s Benzodiazepine Task Force led by Dr. Carl Salzman, 40 to 80% of patients stopping benzodiazepines experience withdrawal. A review by Nassima et al concluded that the FDA’s Xanax cessation recommendations are too fast and recommend not exceeding 0.125 mg reductions weekly.  0.125 mg is half of the smallest available Xanax pill (0.25 mg), so that number may have been chosen out of convenience, not necessarily optimal  patient  outcomes. While Nassima et al’s conclusions may work for some, they have still proven far too fast for many patients, and this illustrates the absolute need for the drug to be made available in smaller doses.  With 40 to 80% of patients experiencing withdrawal, and more than 90 million prescriptions written in the United States annually, it is critical that stopping a benzodiazepine be as safe and simple as possible.

What Taper Rate Is Most Successful?

1/4th of a 0.25mg Generic Xanax (Alprazolam)

According to Schweizer et al, reductions implemented by many physicians of 25% per week have a 32-42% failure rate.  A recommended safe taper with a reported patient success rate of over 90% is outlined in the Ashton Manual. The Ashton Manual recommends a reduction rate of around 5 to 10% every two to four weeks, with an important disclaimer that some patients may need to proceed at an even lower rate or remain at the lowered dosage for longer periods before reducing again, based on patient symptoms.  Ashton does not recommend for anyone to end their taper of a benzodiazepine above an equivalence of 0.1 mg of Xanax which is less than a half of a 0.25 mg pill, and suggests ending as low as the equivalent of 0.025 mgs of Xanax, which is merely crumbs of the total pill.  How does a patient reduce a tiny, but potent, Xanax tablet to 0 milligrams in 5-10% reductions or less?  Not without great difficulty with the currently available options.   Due to accuracy issues and other concerns with pill splitting, especially potent ones like Xanax, one can see how the currently available dosages for discontinuation are dangerously deficient.  Breaking a pill in half is well out of optimal range for both taper speed and taper rate.

Other methods developed, namely by patients desperate to discontinue these drugs, suggest tapering to an even lower dose prior to stopping, finding that microtapering (reducing by tiny micrograms per day) to 0 mg is even more tolerable and successful for patients.  Depending on the patient’s geographical location, some benzodiazepines, including Xanax, are available in a liquid formulation but the sole concentration (1mg/1mL) option available may not benefit the patient in their taper without additional patient burden as it may require further dilution to allow for concentration of drug that is conducive to microtapering at the rate required for that patient.  

Redress is Urgently Needed to Help Patients

While many creative tapering solutions to this problem exist, mostly developed by patients or sometimes in cooperation with outside-the-box-thinking pharmacists, most of them still remain potentially inaccurate, unnecessarily complicated, and/or financially burdensome to the patient.  One physician in the Netherlands, Dr. Peter Groot, faced with this issue during his own prescribed medication dependence, attempted to solve this problem by inventing his own tapering strips, making many drugs available in smaller doses for tapering, which are now available for direct order in Europe.  Since patients already bear enough of the withdrawal burden, often unexpectedly and without having been warned of this risk, they shouldn’t have to alter dangerous medications to safely discontinue them. Further confounding the problem, many of the available taper methods (making your own at-home liquids, shaving pills to weigh on a scale, etc.) are confusing, require many steps, a steady hand, and math skills to be successful from patients who are already both physically and cognitively impaired from the drug and withdrawal itself.  If the goal is to help patients succeed in benzodiazepine cessation, the resources to do so need to be readily available and affordable. Writing off a majority of benzodiazepine-dependent patients as “resistant” without further solutions is an unacceptable and lazy response to a problem with potentially devastating and painful outcomes.

The obvious and simple solution would be for the FDA to require the manufacturing of smaller doses of benzodiazepines. This would allow patients the ability to follow a safe and tolerable taper plan from their current dose to zero milligrams without the need to implement risky at-home methods or afford expensive (and often not covered by insurance) professional pharmaceutical compounding, facilitating accurate dosing and tolerable symptoms as they take on benzodiazepine cessation.  This solution would aid all parties by broadening the prescriber’s toolkit while assisting patients who choose to withdraw in a less onerous manner.