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Dosing Guidance for SUBOXONE & SUBUTEX® Short- and Long-term Medical Withdrawal (ie, Detoxification) — Inpatient and Outpatient

The goal of medical withdrawal is to rapidly achieve control of withdrawal symptoms so patients can fully participate in treatment, including medical, psychosocial, psychiatric, etc. SUBOXONE (buprenorphine HCl/naloxone HCI dihydrate) or SUBUTEX (buprenorphine HCl) sublingual tablets have been shown to be effective treatments in relieving withdrawal symptoms during medical withdrawal (ie, detoxification) from short-acting opioids and are comparable to, or superior to, other pharmacologic treatment options.1 SUBUTEX can be administered in a residential setting or physician's office since it will be administered under supervision. SUBOXONE is the preferred medication for use at home.

The following procedure is recommended:

Other withdrawal medications are not routinely required; however, in the event of sleep disturbances, limited amounts of hypnotic or sedative agents (eg, 5-10 mg zolpidem, 10-20 mg temazepam, or trazadone 50-100 mg as sleep aid for 2 nights) may be prescribed. If benzodiazepines are prescribed: instruct the patient that severe, potentially lethal, reactions may result from misuse of SUBOXONE or SUBUTEX with benzodiazepines, especially when the two are misused together by injection.

Outpatient or inpatient dosing regimen

1. Outpatient dosing regimen
A short-term flexible 5 to 8 day and fixed 20 to 36 day SUBOXONE or SUBUTEX sublingual tablets-managed medical withdrawal (ie, detoxification) are shown.

Outpatient Dosing Regimen for Opioid Medical Withdrawal

a) Flexible Dosing Schedule for Buprenorphine:
Day Recommended upper and
lower limits
Recommended buprenorphine dose
1 4 to 8 mg 6 mg
2 4 to 12 mg 8 mg
3 4 to 16 mg 10 mg
4 2 to 12 mg 8 mg
5 0 to 8 mg 4 mg
6 0 to 4 mg
7 0 to 2 mg
8 0 mg
Lintzeris N, Clark NC, Muhleisen P, et al. National Clinical Guidelines on the Use of Buprenorphine in the Management of Heroin Dependence. Canberra: National Drug Strategy, Commonwealth of Australia; 2001.

b) Fixed Dosing Schedule:

2. Inpatient dosing regimen

Flexible and fixed dosing schedule with SUBOXONE or SUBUTEX as shown below.

Inpatient Dosing Regimen for Opioid Medical Withdrawal

a) Flexible Dosing Schedule:
Day Recommended buprenorphine dose Total daily dose
1 4 mg at onset of withdrawal, and additional
2 to 4 mg evening dose prn
4 to 8 mg
2 4 mg morning, with additional
2 to 4 mg evening dose prn
4 to 8 mg
3 4 mg morning, with additional
2 mg evening dose prn
4 to 6 mg
4 2 mg morning prn; 2 mg evening prn 0 to 4 mg
5 2 mg prn 0 to 2 mg
6 no dose
7 no dose
Lintzeris N, Bammer G, Rushworth L, Jolley DJ. Whelian G. Drug Alcohol Depend. 2003;70:287-294.

b) Fixed Dosing Schedule:

Buprenorphine dose
Day 10-day 7-day 3-day
1 8 mg 8 mg 12 mg
2 6 mg 6 mg 8 mg
3 4 mg 4 mg 8 mg
4 4 mg 4 mg
5 4 mg 2 mg
6 2 mg 2 mg
7 2 mg 0 mg
8 2 mg
9 2 mg
10 0 mg
Johnson RE, Strain EC, Amass L. Drug Alcohol Depend. 2003;70(suppl 2):S59-S77.

After the withdrawal episode
Having successfully become abstinent, patients should be encouraged to consider further treatment options to help them stay away from opioids. The options should be discussed as early as possible, including the possibility for ongoing psychosocial support and counseling, maintenance therapy, naltrexone treatment, self-help groups, or residential rehabilitation programs. Occasionally patients may, following medical withdrawal, request to be maintained on SUBOXONE sublingual tablets (see induction protocol in these guidelines).