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Amlodipine Sleep Architecture Impact: What the Evidence Actually Shows

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At a glance

  • Drug class / dihydropyridine calcium channel blocker [1]
  • Labeled doses / 2.5, 5 and 10 mg once daily [1]
  • Half-life / about 30 to 50 hours; steady state in 7 to 8 days [1]
  • Somnolence / 1.4% on amlodipine vs 0.6% on placebo [1]
  • Fatigue / 4.5% vs 2.8% on placebo [1]
  • Insomnia and abnormal dreams / listed under 1% of patients, causality uncertain [1]
  • Edema / 1.8%, 3.0% and 10.8% at 2.5, 5 and 10 mg vs 0.6% on placebo [1]

What does the Norvasc label record about sleep and drowsiness?

In placebo-controlled trials, 1,730 patients received amlodipine at doses up to 10 mg and 1,250 received placebo [1]. In those trials, somnolence was reported in 1.4% of amlodipine patients versus 0.6% on placebo, and fatigue in 4.5% versus 2.8%; neither was clearly dose related [1]. For comparison, the dose-related events were edema, dizziness, flushing and palpitation [1].

Insomnia, abnormal dreams, nervousness, anxiety and depression appear in a separate list of events reported in more than 0.1% but fewer than 1% of patients in controlled trials, open trials or marketing experience, where the label states a causal relationship is uncertain [1]. Nocturia appears in that same list [1]. Discontinuation because of adverse reactions was about 1.5% on amlodipine versus about 1% on placebo [1].

So the label's sleep-related entries are counts of reported symptoms, not sleep recordings.

Does amlodipine change REM sleep or slow-wave sleep?

The label's adverse-reaction data are symptom reports, and they include no measurements of REM percentage, slow-wave percentage, sleep latency or sleep efficiency [1].

The only dream-related entry is "abnormal dreams," which the label places in the under-1% list with causality uncertain [1]. That is a symptom report, not a finding from a sleep study.

Does once-daily amlodipine cover the night?

Amlodipine has a terminal elimination half-life of about 30 to 50 hours and reaches steady state after 7 to 8 days of daily dosing [1]. The label states that with chronic once-daily oral administration, antihypertensive effectiveness is maintained for at least 24 hours [1]. It is a peripheral arterial vasodilator with a gradual onset of effect, described in the label as resulting from a gradual rate of association with and dissociation from the calcium channel receptor [1].

On heart rate, the label's pharmacology section states that blood pressure reductions with chronic oral dosing are not accompanied by a significant change in heart rate or plasma catecholamine levels [1].

How common is ankle swelling?

Edema is the most common adverse reaction and rises steeply with dose: 1.8% at 2.5 mg, 3.0% at 5 mg and 10.8% at 10 mg, against 0.6% on placebo [1]. It was more frequent in women (14.6% versus 5.1% on placebo) than in men (5.6% versus 1.4%) [1].

Frequently asked questions

Does amlodipine cause insomnia?
Insomnia appears in the Norvasc label among events reported in more than 0.1% but fewer than 1% of patients, where the label says a causal relationship is uncertain [1]. Somnolence, by contrast, was reported in 1.4% of patients versus 0.6% on placebo [1].
Does amlodipine cause nightmares or vivid dreams?
The only dream-related entry in the label is abnormal dreams, listed among events in fewer than 1% of patients with causality uncertain [1]. Depression, anxiety and nervousness appear in the same list [1].
Does amlodipine cause daytime sleepiness?
Somnolence was reported in 1.4% of patients on amlodipine versus 0.6% on placebo, and fatigue in 4.5% versus 2.8%; neither was clearly dose related [1].
Does once-daily amlodipine last through the night?
The labeled regimen is once daily, the terminal half-life is about 30 to 50 hours, and steady state is reached after 7 to 8 days [1]. The label states that with chronic once-daily oral dosing, antihypertensive effectiveness is maintained for at least 24 hours [1].
How common is ankle swelling with amlodipine?
Edema is the most common adverse reaction and is dose related: 1.8% at 2.5 mg, 3.0% at 5 mg and 10.8% at 10 mg versus 0.6% on placebo [1]. It was more frequent in women than men [1].

References

  1. U.S. National Library of Medicine, DailyMed. Norvasc amlodipine besylate tablets (Viatris Specialty) prescribing information. Norvasc amlodipine besylate tablets (Viatris Specialty) label
Evidence overview for amlodipine: Amlodipine Sleep Architecture Impact: What the Evidence Actually Shows