HOW NOT TO TAKE ZOLPIDEMTHE CASE
Despite public anxiety, the Australian Therapeutic Goods Administration (TGA) decided this week (21/02/2008) not to ban Zolpidem or even reclassify it as a "Controlled Drug" also known as "Schedule 8". So be it, we are not party to the facts they considered, and for the time being let us assume they have made the right decision.
If zolpidem is to remain on the Australian market then it must be used correctly.
TO PRESCRIBERS (DOCTORS)
The official indication for zolpidem is "Short-term treatment of insomnia in adults". Don't prescribe it for continuous therapy, it isn't indicated for this nor did Sanofi test it for this.
Write prescriptions for the smallest quantities necessary. Preferably specify seven tablets or at the maximum fourteen tablets, no more. Some authorities consider that it may be malpractice to prescribe more than fourteen tablets at a time.
If you really must write repeat prescriptions then please specify the time interval before the repeat can be filled by the pharmacy.
Do not write prescriptions for large quantities in the mistaken belief you are doing patients a favour by saving them money.
The correct dose is always one tablet at night, the tablets are available as 10mg, 6.25 mg or 12.5 mg. The latter two strengths are "controlled release" tablets where the drug is released more slowly into the blood stream.
The dose for elderly or debilitated patients is 5 mg at night (half a 10mg tablet).
The patient will not gain any therapeutic benefit from taking more than one tablet at night, however the likelihood of side-effects will increase.
Remember to write "Take one tablet at night only if needed", not "Take one or two tablets at night" and definitely not "Take as directed".
Never, ever, prescribe zolpidem to children, teenagers under 18 or alcohol abusers.
Be wary with patients who have psychiatric disorders, substance abuse history, respiratory disease, liver damage, kidney disease, depression, psychosis, schizophrenia, epilepsy or who are pregnant or breastfeeding.
TO PHARMACISTS (CHEMISTS)
Everything above plus:
Don't dispense more than fourteen tablets at a time just because the doctor has written a larger quantity. It is your professional responsibility. The TGA has also recommended this.
Don't offer to save the patient money by dispensing the original prescription and the repeats at the same time, this is legally and morally wrong.
Issue a CMI available here.
Counsel the patient to store sleeping tablets safely - not within reach of the bed and preferably in a different room.
Instruct patients not to drink alcohol whilst taking zolpidem.
The correct instruction is "Take one tablet at night only if needed for sleep". If the prescriber has written a higher dose remember that you are a professional - query the dose!
TO PATIENTS
Listen to your doctor, don't request larger quantities.
Listen to your pharmacist, don't expect more than fourteen tablets at a time.
Read the information the pharmacist has provided (CMI). Available here.
Don't take zolpidem every night, it will stop working.
Don't take more than one tablet at night it won't help, and you may regret it.
Store your tablets out of reach of your bed, so your can't accidentally take multiple doses while you are drowsy.
TO THE FAMILY OF PATIENTS TAKING ZOLPIDEM
Read the information provided by the pharmacist. Available here
Don't let the patient take more than one tablet, it is dangerous.
Don't let the patient drink alcohol while taking zolpidem, it is dangerous.
Don't ignore even a single episode of bizarre behaviour, get help immediately. See here for some reported episodes.
TO INTERNET AND DISCOUNT PHARMACIES
SHAME ON YOU! A quick check on the net showed that Australian Online pharmacies are still listing multiple packs of zolpidem, despite the TGA recommendation. I found prices for Stilnox 10mg Tablets 14 x 3, Stilnox CR 6.25mg 14 Tablets x 3 and Stilnox cr 12.5mg 14 Tablets x 3. Newspaper adverts for discount pharmacies also showed these in the price lists. Just because you are offering "cheap" medicines it does not mean the rules don't apply to you. It is illegal for you to dispense the original prescription and the repeats at the same time. It is also unprofessional and immoral.
MY VERDICT
If everybody followed the advice above, zolpidem would probably be a very safe drug. However I predict that the TGA will reschedule it within twelve months.
RELATED STORIES
"Heath Ledgers cocktail - what happened to the zolpidem?"
Despite public anxiety, the Australian Therapeutic Goods Administration (TGA) decided this week (21/02/2008) not to ban Zolpidem or even reclassify it as a "Controlled Drug" also known as "Schedule 8". So be it, we are not party to the facts they considered, and for the time being let us assume they have made the right decision.
If zolpidem is to remain on the Australian market then it must be used correctly.
TO PRESCRIBERS (DOCTORS)
The official indication for zolpidem is "Short-term treatment of insomnia in adults". Don't prescribe it for continuous therapy, it isn't indicated for this nor did Sanofi test it for this.
Write prescriptions for the smallest quantities necessary. Preferably specify seven tablets or at the maximum fourteen tablets, no more. Some authorities consider that it may be malpractice to prescribe more than fourteen tablets at a time.
If you really must write repeat prescriptions then please specify the time interval before the repeat can be filled by the pharmacy.
Do not write prescriptions for large quantities in the mistaken belief you are doing patients a favour by saving them money.
The correct dose is always one tablet at night, the tablets are available as 10mg, 6.25 mg or 12.5 mg. The latter two strengths are "controlled release" tablets where the drug is released more slowly into the blood stream.
The dose for elderly or debilitated patients is 5 mg at night (half a 10mg tablet).
The patient will not gain any therapeutic benefit from taking more than one tablet at night, however the likelihood of side-effects will increase.
Remember to write "Take one tablet at night only if needed", not "Take one or two tablets at night" and definitely not "Take as directed".
Never, ever, prescribe zolpidem to children, teenagers under 18 or alcohol abusers.
Be wary with patients who have psychiatric disorders, substance abuse history, respiratory disease, liver damage, kidney disease, depression, psychosis, schizophrenia, epilepsy or who are pregnant or breastfeeding.
TO PHARMACISTS (CHEMISTS)
Everything above plus:
Don't dispense more than fourteen tablets at a time just because the doctor has written a larger quantity. It is your professional responsibility. The TGA has also recommended this.
Don't offer to save the patient money by dispensing the original prescription and the repeats at the same time, this is legally and morally wrong.
Issue a CMI available here.
Counsel the patient to store sleeping tablets safely - not within reach of the bed and preferably in a different room.
Instruct patients not to drink alcohol whilst taking zolpidem.
The correct instruction is "Take one tablet at night only if needed for sleep". If the prescriber has written a higher dose remember that you are a professional - query the dose!
TO PATIENTS
Listen to your doctor, don't request larger quantities.
Listen to your pharmacist, don't expect more than fourteen tablets at a time.
Read the information the pharmacist has provided (CMI). Available here.
Don't take zolpidem every night, it will stop working.
Don't take more than one tablet at night it won't help, and you may regret it.
Store your tablets out of reach of your bed, so your can't accidentally take multiple doses while you are drowsy.
TO THE FAMILY OF PATIENTS TAKING ZOLPIDEM
Read the information provided by the pharmacist. Available here
Don't let the patient take more than one tablet, it is dangerous.
Don't let the patient drink alcohol while taking zolpidem, it is dangerous.
Don't ignore even a single episode of bizarre behaviour, get help immediately. See here for some reported episodes.
TO INTERNET AND DISCOUNT PHARMACIES
SHAME ON YOU! A quick check on the net showed that Australian Online pharmacies are still listing multiple packs of zolpidem, despite the TGA recommendation. I found prices for Stilnox 10mg Tablets 14 x 3, Stilnox CR 6.25mg 14 Tablets x 3 and Stilnox cr 12.5mg 14 Tablets x 3. Newspaper adverts for discount pharmacies also showed these in the price lists. Just because you are offering "cheap" medicines it does not mean the rules don't apply to you. It is illegal for you to dispense the original prescription and the repeats at the same time. It is also unprofessional and immoral.
MY VERDICT
If everybody followed the advice above, zolpidem would probably be a very safe drug. However I predict that the TGA will reschedule it within twelve months.
RELATED STORIES
"Zolpidem tall tales and true make sad reading"
"Sleep drug zolpidem facing withdrawal?"
"Heath Ledger - another victim of zolpidem?"
"Further restrictions on zolpidem likely in Australia"
"Heath Ledgers cocktail - what happened to the zolpidem?"
1 comments:
While it is important for providers to counsel their patients, it is also important that they remember not to cross the line the separates sound decision making from paternalistic zealousy. We must respect the fact that if a competent adult wishes to take a prescription sleep aid, they have every right to do so. The law provides doctors and pharmacists with authority to prescribe and dispense in line with the expertise of the professions. I don't think the law ever intended to nanny or hinder law abiding adult citizens.
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