Trial reportBritish journal of clinical pharmacology2014
Melatonin for sedative withdrawal in older patients with primary insomnia: a randomized double-blind placebo-controlled trial.
Trial report in British journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 54 citations in OpenAlex.
- Joint Clinical Practice Guideline on Benzodiazepine Tapering: Considerations When Risks Outweigh Benefits.Journal of general internal medicine · 2025Guideline
- Comparative effectiveness of interventions to facilitate deprescription of benzodiazepines and other sedative hypnotics: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2025Pooled it
- Pharmacological interventions for benzodiazepine discontinuation in chronic benzodiazepine users.The Cochrane database of systematic reviews · 2018Pooled it
- The feasibility and effect of deprescribing in older adults on mortality and health: a systematic review and meta-analysis.British journal of clinical pharmacology · 2016Pooled it
- The Effect of Melatonin on Benzodiazepine Discontinuation and Sleep Quality in Adults Attempting to Discontinue Benzodiazepines: A Systematic Review and Meta-Analysis.Drugs & aging · 2015Pooled it
- Melatonin Bioavailability After Oral Administration of a New Delayed-Release Form in Healthy Male Volunteers.Drugs in R&D · 2024Trial
- Bioavailability of Melatonin after Administration of an Oral Prolonged-Release Tablet and an Immediate-Release Sublingual Spray in Healthy Male Volunteers.Drugs in R&D · 2023Trial
- Long-term persistence of withdrawal of temazepam, zopiclone, and zolpidem in older adults: a 3-year follow-up study.BMC geriatrics · 2018Trial
- Handgrip strength and balance in older adults following withdrawal from long-term use of temazepam, zopiclone or zolpidem as hypnotics.BMC geriatrics · 2014Trial
- Primary Care Prescribing Patterns for Benzodiazepines and Z-Drugs, and Evidence Gaps Concerning Hydroxyzine and Seasonality: A Systematic Review.Clinics and practice · 2026Review
- Melatonin: A Review of the Evidence for Use in Hospital Settings.Pharmacology research & perspectives · 2025Review
- A scoping review of over-the-counter products for depression, anxiety and insomnia in older people.BMC complementary medicine and therapies · 2024Article
- Review
- Insights into patient characteristics and documentation of the use of sedative-hypnotic/anxiolytics in primary care: a retrospective chart review study.BMC primary care · 2022Article
- Cognitive Behavioral Therapy and Acceptance and Commitment Therapy for the Discontinuation of Long-Term Benzodiazepine Use in Insomnia and Anxiety Disorders.International journal of environmental research and public health · 2021Review
- Metabolic diversity as a reason for unsuccessful detoxification from benzodiazepines: the rationale for serum BZD concentration monitoring.European journal of clinical pharmacology · 2021Review
- Are Older People Aware of Potential Risks Related to Benzodiazepines They are Taking and Has Anything Changed in Risk Awareness Over Ten Years?Patient preference and adherence · 2021Article
- Collaborative Medication Reviews to Identify Inappropriate Prescribing in Pre-Admission Medications at Emergency Department Short-Term Ward.Integrated pharmacy research & practice · 2021Article
- Myasthenia gravis exacerbation after melatonin administration: case series from a tertiary referral centre.BMC neurology · 2020Article
- The Glymphatic System in Diabetes-Induced Dementia.Frontiers in neurology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimWe compared the efficacy of melatonin and placebo as adjuvants in the withdrawal of patients from long term temazepam, zopiclone or zolpidem (here 'BZD') use.
methodsA double-blind, placebo-controlled, randomized trial was conducted in a primary health care outpatient clinic. Ninety-two men or women (≥55 years) with primary insomnia and chronic BZD use received controlled release melatonin 2 mg (CRM) (n = 46) or placebo (n = 46) during the 1 month withdrawal from BZDs. Psychosocial support was provided. Follow-up continued for up to 6 months. Successful BZD withdrawal by the end of 1 month was confirmed by BZD plasma determinations, while reduction in BZD use and abstinence continuing for 6 months were noted.
resultsThere were two drop-outs on CRM and one on placebo. After a 1 month withdrawal, 31 participants (67%; 95% CI 54, 81) on CRM and 39 (85%; 74, 95) on placebo had withdrawn completely (intention-to-treat analysis between groups, P = 0.051; per protocol P = 0.043). Reduction in BZD use was similar or even more rare in the CRM than in the placebo group (P = 0.052 per protocol). After 6 months, 14 participants in the CRM group and 20 in the placebo group remained non-users of BZD (NS between groups). BZD doses were higher in the CRM than in the placebo group at the end of the 6 month follow-up (P = 0.025). Withdrawal symptoms did not differ between the groups.
conclusionsGradual dose reduction of BZDs combined with CRM or placebo, and psychosocial support produced high short term and moderate long term BZD abstinence. CRM showed no withdrawal benefit compared with placebo.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.