What risk can be expected during long-term treatment with Theralen (alimemazine)?/nA 30-year-old fe

Fråga: What risk can be expected during long-term treatment with Theralen (alimemazine)?

A 30-year-old female patient with insomnia is taking 30 drops=30 mg alimemazine a day, with good results since she was a teenager. Can she continue without risk for serious side-effects, especially tardive dyskinesia?

Sammanfattning: Neuroleptic side-effects of the tardive type can occur after long-term treatment with neuroleptics, but only one case of alimemazine and tardive dyskinesia could be found in the literature. In the present case a relative low-dose is prescribed. However, unnecessary long-term use of drugs belonging to the neuroleptic group is not recommended.

Svar: Theralen (alimemazine) is a high-dose neuroleptic, belonging to the phenothiazine group. Its adverse effects on the central nervous system are said to be of a low degree (1).

Apart from the anticholinergic side-effects that can appear during treatment with neuroleptics, neurological side-effects of the tardive type can develop slowly, after chronic medication for a minimum of three months but more often after several years. Older patients and women are at slightly higher risk. A dose level above 300 mg chlorpromazine equivalents is also considered to increase the risk of development of tardive dyskinesia (2).

Another side-effect that can appear after prolonged medication with phenothiazine is lens deposits. This adverse effect is considered to be related to dose and duration of therapy (3).

In a Medline-search we found only one report where alimemazine was mentioned in combination with dyskinesia and pseudo-parkinson in an aged patient in a nursing home (4). No further information concerning this could be found in the literature.

With a possible or probable relationship to the drug a total of 29 adverse effects during treatment with alimemazine have been reported to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC) during the years 1973-95. None of the neurological side-effects (two cases of epileptic seizure, one case of dystonia and one case of tremor), developed after more than eight weeks of treatment. 1 Fass 1995; page 949 2 Treatment with neuroleptics. Workshop; National Board of Health and Welfare Drug Information Committee, Sweden 1990:1 (enclosed) 3 Drugline nr 09908 (year 1993) (enclosed) 4 Ondo WG, Hurwitz BJ: Tardive dyskinesia and pseudo-parkinsonism. In a nursing home patient who itched. N C Med J 1993; 54: 605-607 (via Medline)