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Facilitation of benzodiazepine discontinuation by melatonin: a new clinical approach.
Arch Intern Med 1999; 159(20):2456-60AI

Abstract

BACKGROUND

Benzodiazepines are the most frequently used drug for the treatment of insomnia. Prolonged use of benzodiazepine therapy is not recommended. However, many patients, particularly older patients, have difficulties discontinuing therapy. Melatonin, a hormone that is produced at night by the pineal gland, promotes normal sleep in humans and augments sleep induction by benzodiazepine therapy.

OBJECTIVE

To assess whether the administration of melatonin could facilitate the discontinuation of benzodiazepine therapy in patients with insomnia.

METHODS

Thirty-four subjects receiving benzodiazepine therapy were enrolled in the 2-period study. In period 1, patients received (double-blinded) melatonin (2 mg in a controlled-release formulation) or a placebo nightly for 6 weeks. They were encouraged to reduce their benzodiazepine dosage 50% during week 2, 75% during weeks 3 and 4, and to discontinue benzodiazepine therapy completely during weeks 5 and 6. In period 2, melatonin was administered (single-blinded) for 6 weeks to all subjects and attempts to discontinue benzodiazepine therapy were resumed. Benzodiazepine consumption and subjective sleep-quality scores were reported daily by all patients. All subjects were then allowed to continue melatonin therapy and follow-up reassessments were performed 6 months later.

RESULTS

By the end of period 1, 14 of 18 subjects who had received melatonin therapy, but only 4 of 16 in the placebo group, discontinued benzodiazepine therapy (P = .006). Sleep-quality scores were significantly higher in the melatonin therapy group (P = .04). Six additional subjects in the placebo group discontinued benzodiazepine therapy when given melatonin in period 2. The 6-month follow-up assessments revealed that of the 24 patients who discontinued benzodiazepine and received melatonin therapy, 19 maintained good sleep quality.

CONCLUSION

Controlled-release melatonin may effectively facilitate discontinuation of benzodiazepine therapy while maintaining good sleep quality.

Authors+Show Affiliations

Aging Research and the Department of Internal Medicine, The E. Wolfson Medical Center, Holon, Israel.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10665894

Citation

Garfinkel, D, et al. "Facilitation of Benzodiazepine Discontinuation By Melatonin: a New Clinical Approach." Archives of Internal Medicine, vol. 159, no. 20, 1999, pp. 2456-60.
Garfinkel D, Zisapel N, Wainstein J, et al. Facilitation of benzodiazepine discontinuation by melatonin: a new clinical approach. Arch Intern Med. 1999;159(20):2456-60.
Garfinkel, D., Zisapel, N., Wainstein, J., & Laudon, M. (1999). Facilitation of benzodiazepine discontinuation by melatonin: a new clinical approach. Archives of Internal Medicine, 159(20), pp. 2456-60.
Garfinkel D, et al. Facilitation of Benzodiazepine Discontinuation By Melatonin: a New Clinical Approach. Arch Intern Med. 1999 Nov 8;159(20):2456-60. PubMed PMID: 10665894.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Facilitation of benzodiazepine discontinuation by melatonin: a new clinical approach. AU - Garfinkel,D, AU - Zisapel,N, AU - Wainstein,J, AU - Laudon,M, PY - 2000/2/9/pubmed PY - 2000/2/26/medline PY - 2000/2/9/entrez SP - 2456 EP - 60 JF - Archives of internal medicine JO - Arch. Intern. Med. VL - 159 IS - 20 N2 - BACKGROUND: Benzodiazepines are the most frequently used drug for the treatment of insomnia. Prolonged use of benzodiazepine therapy is not recommended. However, many patients, particularly older patients, have difficulties discontinuing therapy. Melatonin, a hormone that is produced at night by the pineal gland, promotes normal sleep in humans and augments sleep induction by benzodiazepine therapy. OBJECTIVE: To assess whether the administration of melatonin could facilitate the discontinuation of benzodiazepine therapy in patients with insomnia. METHODS: Thirty-four subjects receiving benzodiazepine therapy were enrolled in the 2-period study. In period 1, patients received (double-blinded) melatonin (2 mg in a controlled-release formulation) or a placebo nightly for 6 weeks. They were encouraged to reduce their benzodiazepine dosage 50% during week 2, 75% during weeks 3 and 4, and to discontinue benzodiazepine therapy completely during weeks 5 and 6. In period 2, melatonin was administered (single-blinded) for 6 weeks to all subjects and attempts to discontinue benzodiazepine therapy were resumed. Benzodiazepine consumption and subjective sleep-quality scores were reported daily by all patients. All subjects were then allowed to continue melatonin therapy and follow-up reassessments were performed 6 months later. RESULTS: By the end of period 1, 14 of 18 subjects who had received melatonin therapy, but only 4 of 16 in the placebo group, discontinued benzodiazepine therapy (P = .006). Sleep-quality scores were significantly higher in the melatonin therapy group (P = .04). Six additional subjects in the placebo group discontinued benzodiazepine therapy when given melatonin in period 2. The 6-month follow-up assessments revealed that of the 24 patients who discontinued benzodiazepine and received melatonin therapy, 19 maintained good sleep quality. CONCLUSION: Controlled-release melatonin may effectively facilitate discontinuation of benzodiazepine therapy while maintaining good sleep quality. SN - 0003-9926 UR - https://www.unboundmedicine.com/medline/citation/10665894/Facilitation_of_benzodiazepine_discontinuation_by_melatonin:_a_new_clinical_approach_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/vol/159/pg/2456 DB - PRIME DP - Unbound Medicine ER -