Treating insomnia symptoms with medicinal cannabis: a randomized, crossover trial of the efficacy of a cannabinoid medicine compared with placebo
Walsh et al.·SLEEPImpact 0.6
Klarer NutzenGRADEModerat113 Zitate
Stichproben = 23 Pat.
Dauer2 Wochen
KontrollePlacebo
EndpunktISI
Verblindungdoppelblind
DesignRCT
Applikationoromukosal
”Kernaussage
ZTL-101 verbesserte signifikant die Insomnia-Schwere (ISI -5,07), erhöhte die Gesamtschlafdauer (+64,6 min) und die Schlafqualität im Vergleich zu Placebo, mit guter Verträglichkeit.
Zusammenfassung
RCT (cross-over) mit n=23 Patienten (chronische Insomnie ≥3 Monate), 2 Wochen nächtlich sublingualer Cannabinoid-Extrakt (ZTL-101) vs. Placebo. ZTL-101 reduzierte ISI um -5,07 Einheiten (95% CI [-7,28 bis -2,86], p=0,0001), selbstberichtete Einschlaflatenz um -8,45 min (p=0,04), erhöhte Gesamtschlafzeit um +64,6 min (p<0,0001) und Schlafqualität um +0,74 Einheiten (p<0,0001). Aktigraphie: WASO -10,2 min (p=0,002), TST +33,4 min (p<0,001), SE +2,9% (p=0,005). Keine schwerwiegenden Nebenwirkungen; 40 milde nicht-schwerwiegende Ereignisse (36 unter ZTL-101).
P
PopulationErwachsene mit chronischer Insomnie (Symptome ≥3 Monate), n=23 (20 weiblich, mittleres Alter 53±9 Jahre)
Study Objectives: This randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the safety and efficacy of 2 weeks of nightly sublingual cannabinoid extract (ZTL-101) in treating chronic insomnia (symptoms >/=3 months).
Methods: Co-primary study endpoints were safety of the medication based on adverse event reporting and global insomnia symptoms (Insomnia Severity Index [ISI]). Secondary endpoints included: self-reported (sleep diary), actigraphy-derived, and polysomnography measurements of sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), sleep efficiency (SE); and self-reported assessments of sleep quality (sSQ) and feeling rested upon waking. Adjusted mean differences between placebo and ZTL-101 were calculated.
Results: Twenty-three of 24 randomized participants (n = 20 female, mean age 53 +/- 9 years) completed the protocol. No serious adverse events were reported. Forty mild, nonserious, adverse events were reported (36 during ZTL-101) with all but one resolving overnight or soon after waking. Compared to placebo, ZTL-101 decreased ISI (-5.07 units [95% CI: -7.28 to -2.86]; p = 0.0001) and self-reported SOL (-8.45 min [95% CI: -16.33 to -0.57]; p = 0.04) and increased self-reported TST (64.6 min [95% CI: 41.70 to 87.46]; p < 0.0001), sSQ (0.74 units [95% CI: 0.51 to 0.97]; p < 0.0001), and feeling of being rested on waking (0.51 units [95% CI: 0.24 to 0.78]; p = 0.0007). ZTL-101 also decreased actigraphy-derived WASO (-10.2 min [95% CI: -16.2 to -4.2]; p = 0.002), and increased actigraphy-derived TST (33.4 min [95% CI: 23.07 to 43.76]; p < 0.001) and SE (2.9% [95% CI: 2.0 to 3.8]; p = 0.005).
Conclusions: Two weeks of nightly sublingual administration of a cannabinoid extract (ZTL-101) is well tolerated and improves insomnia symptoms and sleep quality in individuals with chronic insomnia symptoms.
Clinical Trial: ANZCTR; anzctr.org.au; ACTRN12618000078257.