Drug Points: Sleep disturbance in children treated with ofloxacin

BMJ 1994; 309 doi: (Published 26 November 1994) Cite this as: BMJ 1994;309:1411
  1. C Upton
  1. (Norfolk and Norwich Hospital, Norfolk NR1 3SR).

    Fluoroquinolones are not licensed for use in children but are the only drugs that act orally against Pseudomonas aeruginosa.1 They are therefore used widely in children with cystic fibrosis and pseudomonas infection. Their use has increased since the finding that treatment with oral ciprofloxacin and nebulised colistin can delay chronic carriage of pseudomonas when given after the organism is first isolated.2 This has become standard practice. This hospital's pharmacy recently changed the fluoroquinolone on its formulary from ciprofloxacin to ofloxacin. I report here severe sleep disturbance in three children with cystic fibrosis treated with ofloxacin.

    P aeruginosa was cultured from a routine outpatient pharyngeal swab from a 6 year old boy. Treatment was started with nebulised colistin 500000 U twice daily and oral ofloxacin 400 mg twice daily. His sleep became very disturbed (he slept a maximum of only five hours a night), and he developed a light sensitive rash. Nevertheless, we continued the treatment for three weeks, and the symptoms subsequently settled.

    P aeruginosa was cultured from samples taken after a viral illness in another 6 year old boy. He started taking nebulised colistin 500000 U twice daily and oral ofloxacin 200 mg twice daily. He returned after two weeks complaining of nightmares and severe sleep disturbance. Ofloxacin was stopped and colistin continued for a further week, during which the symptoms settled. A subsequent respiratory exacerbation was treated with ciprofloxacin 500 mg twice daily, but he did not develop any sleep disturbance.

    After a course of intravenous antibiotics for a respiratory exacerbation due to P aeruginosa a 10 year old girl had a persistent cough, which was treated with nebulised colistin 500000 U twice daily and oral ofloxacin 400 mg twice daily. She returned 10 days later complaining of an inability to sleep. Colistin was continued but her oral treatment was changed to ciprofloxacin 500 mg twice daily. Her symptoms settled immediately.

    None of the three patients had previously received fluoroquinolone treatment. All continued to receive vitamin supplements and pancreatic enzymes, and the second and third patients also received prophylactic oral flucloxacillin. Doses of these drugs were unchanged and symptoms had not previously occurred with them. The temporal relation makes it almost certain that the symptoms were due to ofloxacin. The last two patients slept well while subsequently taking ciprofloxacin. Both drugs are effective orally against pseudomonas infection in cystic fibrosis in adults.3 Sleep disturbance is a recognised but rare complication of fluoroquinolone treatment, but it has not been related to one specific drug in adult practice.1 3 These observations suggest that sleep disturbance is common in children receiving ofloxacin and that ciprofloxacin is usually well tolerated.


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