Current Scheduling Status
Year(s) and type of review / ECDD meetings
Drug Class
Recommendation (from TRS)
Substance identification
Diazepam is chemically 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one (CAS 439-14-5). It is marketed under numerous trade names.
WHO review history
In 1984, 33 benzodiazepines (including diazepam) were placed in Schedule IV of the 1971 Convention. In 1990, at its twenty-seventh meeting (S), the Committee reassessed all benzodiazepines in schedule IV, at which time it was noted that diazepam and flunitrazepam showed a continuing higher incidence of abuse and association with illicit activities. The Committee therefore recommended that WHO continue to keep diazepam and flunitrazepam under surveillance in order to determine whether they merit being placed under critical review.
In 1998, at its thirty-first meeting (/), the Committee pre-reviewed several benzodiazepines and concluded that flunitrazepam, diazepam and injectable dosage forms of temazepam might have greater abuse liabilities than the other benzodiazepines. Of these three benzodiazepines, the Committee recommended critical review of diazepam only, because flunitrazepam had already been rescheduled to Schedule III and the higher abuse liability of temazepam applied only to its injectable preparation, the availability of which was geographically limited.
Similarity to known substances and effects on the CNS
Diazepam belongs to the benzodiazepine group of substances and has anxiolytic, sedative—hypnotic, anticonvulsant and muscle relaxant effects.
Dependence potential
Studies in both animals and humans have demonstrated that diazepam has reinforcing efficacy and can produce withdrawal symptoms upon discontinuation of long-term use. The reinforcing/subjective effects of various benzodiazepines were compared in a series of experimental studies in subjects with a history of drug abuse, the results of which indicated that diazepam produces greater reinforcing or subjective effects than several of the other benzodiazepines studied.
Actual abuse and or/evidence of likelihood of abuse
Significant abuse of diazepam has been reported worldwide, both in the past and recently. Various studies based on surveys in drug-using populations indicate that flunitrazepam and diazepam are often the preferred benzodiazepines and several epidemiological studies, which have adjusted for drug availability, suggest that rates of abuse of diazepam exceed those of most other benzodiazepines. Nevertheless, examination of reports of dependence from the WHO Adverse Drug Reaction database, adjusted for global consumption, showed that diazepam abuse rates are not as high as those for alprazolam and lorazepam.
Therapeutic usefulness
Diazepam is used widely in medicine, mainly as an anxiolytic sedative, anaesthetic and anti-convulsant. In particular, diazepam is an inexpensive and effective treatment for status epilepticus, a lifethreatening condition. Its use is particularly important in developing countries where alternatives may be unavailable or unaffordable. Diazepam is included in the WHO Model List of Essential Drugs (9).
Recommendation
Experimental studies in humans, surveys and epidemiological studies indicate that diazepam has a greater abuse liability than many of the other benzodiazepines. The Committee also noted that certain other benzodiazepines, such as alprazolam and lorazepam, may be associated with greater abuse liability than diazepam. In view of the wide therapeutic usefulness of diazepam and its important role in medicine in developing countries in particular, the Committee decided that rescheduling of diazepam to a higher level of control is not currently warranted. However, the Committee recommended that WHO continue to keep diazepam under surveillance.
Diazepam is chemically 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one (CAS 439-14-5). It is marketed under numerous trade names.
WHO review history
In 1984, 33 benzodiazepines (including diazepam) were placed in Schedule IV of the 1971 Convention. In 1990, at its twenty-seventh meeting (S), the Committee reassessed all benzodiazepines in schedule IV, at which time it was noted that diazepam and flunitrazepam showed a continuing higher incidence of abuse and association with illicit activities. The Committee therefore recommended that WHO continue to keep diazepam and flunitrazepam under surveillance in order to determine whether they merit being placed under critical review.
In 1998, at its thirty-first meeting (/), the Committee pre-reviewed several benzodiazepines and concluded that flunitrazepam, diazepam and injectable dosage forms of temazepam might have greater abuse liabilities than the other benzodiazepines. Of these three benzodiazepines, the Committee recommended critical review of diazepam only, because flunitrazepam had already been rescheduled to Schedule III and the higher abuse liability of temazepam applied only to its injectable preparation, the availability of which was geographically limited.
Similarity to known substances and effects on the CNS
Diazepam belongs to the benzodiazepine group of substances and has anxiolytic, sedative—hypnotic, anticonvulsant and muscle relaxant effects.
Dependence potential
Studies in both animals and humans have demonstrated that diazepam has reinforcing efficacy and can produce withdrawal symptoms upon discontinuation of long-term use. The reinforcing/subjective effects of various benzodiazepines were compared in a series of experimental studies in subjects with a history of drug abuse, the results of which indicated that diazepam produces greater reinforcing or subjective effects than several of the other benzodiazepines studied.
Actual abuse and or/evidence of likelihood of abuse
Significant abuse of diazepam has been reported worldwide, both in the past and recently. Various studies based on surveys in drug-using populations indicate that flunitrazepam and diazepam are often the preferred benzodiazepines and several epidemiological studies, which have adjusted for drug availability, suggest that rates of abuse of diazepam exceed those of most other benzodiazepines. Nevertheless, examination of reports of dependence from the WHO Adverse Drug Reaction database, adjusted for global consumption, showed that diazepam abuse rates are not as high as those for alprazolam and lorazepam.
Therapeutic usefulness
Diazepam is used widely in medicine, mainly as an anxiolytic sedative, anaesthetic and anti-convulsant. In particular, diazepam is an inexpensive and effective treatment for status epilepticus, a lifethreatening condition. Its use is particularly important in developing countries where alternatives may be unavailable or unaffordable. Diazepam is included in the WHO Model List of Essential Drugs (9).
Recommendation
Experimental studies in humans, surveys and epidemiological studies indicate that diazepam has a greater abuse liability than many of the other benzodiazepines. The Committee also noted that certain other benzodiazepines, such as alprazolam and lorazepam, may be associated with greater abuse liability than diazepam. In view of the wide therapeutic usefulness of diazepam and its important role in medicine in developing countries in particular, the Committee decided that rescheduling of diazepam to a higher level of control is not currently warranted. However, the Committee recommended that WHO continue to keep diazepam under surveillance.
ECDD Recommendation
Placed under surveillance
Link to full TRS
who_trs_903.pdf1.33 MB