Saffron for Sleep Disorders: Efficacy and Evidence
Saffron shows promising effects for improving sleep quality in adults with mild to moderate sleep difficulties, but it is not included in major clinical guidelines for insomnia treatment and lacks the robust evidence of first-line treatments like CBT-I and FDA-approved medications.
Evidence for Saffron's Effects on Sleep
Recent randomized controlled trials have demonstrated several positive effects of saffron on sleep:
A 2021 multi-dose study showed that standardized saffron extract (affron®) at both 14mg and 28mg doses improved sleep quality ratings and insomnia symptoms compared to placebo over 28 days 1
A 2020 double-blind RCT found that 28mg daily of saffron extract (14mg twice daily) was associated with significant improvements in Insomnia Severity Index scores, Restorative Sleep Questionnaire scores, and sleep quality ratings compared to placebo 2
A 2021 study using objective actigraphy measurements demonstrated that 15.5mg daily of saffron extract improved time in bed, ease of getting to sleep, sleep quality, sleep latency, and sleep duration over 6 weeks 3
A 2023 systematic review of 5 randomized clinical trials with 379 participants concluded that saffron appears to have beneficial effects on both duration and quality of sleep 4
Mechanism of Action
Saffron's sleep-promoting effects may be related to:
- Increased evening melatonin concentrations, as observed in a 2021 study 1
- The carotenoid pigment crocin, which has been shown in animal studies to increase non-REM sleep time without affecting REM sleep or causing rebound insomnia 5
Guideline-Recommended Treatments for Insomnia
Current clinical guidelines do not include saffron among recommended treatments for insomnia. Instead, they recommend:
First-Line Treatment:
- Cognitive Behavioral Therapy for Insomnia (CBT-I) is consistently recommended as first-line treatment by major guidelines 6, 7
FDA-Approved Medications:
For pharmacological treatment, guidelines recommend:
- Non-benzodiazepines (eszopiclone, zaleplon, zolpidem) for short-term use 6
- Suvorexant for sleep maintenance insomnia 6
- Ramelteon for sleep onset insomnia 6
- Low-dose doxepin (3-6mg) for sleep maintenance insomnia 6, 7
Complementary and Alternative Treatments:
Guidelines specifically recommend against several complementary treatments:
- Melatonin shows minimal clinical significance with only approximately 7-minute decrease in sleep latency and 8-minute increase in total sleep time 6
- Valerian and chamomile show no significant differences from placebo in critical outcomes 6
- Kava has a strong recommendation against use due to risk of acute liver damage 6
Safety Considerations
- Saffron supplementation appears to be well-tolerated with no significant adverse effects reported in the reviewed studies 1, 2, 3
- In contrast, FDA-approved sleep medications carry risks of cognitive and behavioral changes, complex behaviors (like sleep driving), and potential for dependency 6, 7
- Benzodiazepines and non-benzodiazepine hypnotics may be associated with increased risk for dementia, fractures, and major injury 6
Clinical Application
While saffron shows promise as a natural sleep aid:
- It has not been evaluated in patients with diagnosed insomnia disorder
- Studies have been relatively short-term (28 days to 6 weeks)
- Sample sizes have been modest (55-120 participants)
- More research using objective sleep measures is needed
- It has not been compared directly to standard treatments
Conclusion
Saffron appears to be a promising complementary approach for improving sleep quality in adults with mild to moderate sleep difficulties. However, for diagnosed insomnia disorder, evidence-based treatments recommended in clinical guidelines (CBT-I and FDA-approved medications when appropriate) should remain the primary interventions until more robust evidence for saffron becomes available.