Table 4.

Effect of very low dose cyclobenzaprine (VLD CBP) on sleep EEG.

	Last Observation Carried Forward (LOCF)					SD	LOCF p^*	VLD CBP vs Placebo
	Treatment	Baseline (SD)	Week 8 (SD)	Mean Change	% of Baseline	SD	LOCF p^*	Treatment p^**	% of Baseline
Total time awake, h	VLD CBP	1.3 (0.9)	0.8 (0.5)	–0.5	–38.5	0.74	0.011^†	0.100	0.0
	Placebo	0.9 (0.7)	0.8 (0.5)	–0.1	–11.1	0.50	0.408
Total sleep time, h	VLD CBP	5.7 (1.2)	6.4 (1.1)	0.7	12.3	0.93	0.005^†	0.156	0.0
	Placebo	0.9 (0.7)	0.8 (0.5)	–0.1	–11.1	0.50	0.408
Stage 1, %	VLD CBP	10.3 (3.7)	11.5 (3.8)	1.2	11.7	3.72	0.189	0.205	16.6
	Placebo	10.2 (5.0)	9.8 (4.6)	–0.4	–3.9	3.86	0.666
Stage 2, %	VLD CBP	52.9 (8.1)	56.5 (10.0)	3.5	6.8	9.04	0.119	0.021^†	11.1
	Placebo	53.2 (6.7)	50.6 (6.8)	–2.6	–4.9	5.87	0.077
Stage 3, %	VLD CBP	7.4 (3.3)	8.6 (4.3)	1.2	16.2	3.52	0.166	0.166	21.9
	Placebo	7.2 (2.2)	7 (1.9)	–0.2	–2.8	2.04	0.683
Stage 4, %	VLD CBP	10.5 (7.8)	7.5 (8.0)	–3.0	–28.6	7.64	0.114	0.029^†	–55.1
	Placebo	10.9 (5.5)	13.4 (5.5)	2.5	22.9	6.81	0.138
REM, %	VLD CBP	18.8 (5.2)	15.9 (5.1)	–2.9	–15.4	4.18	0.764	0.007^†	–17.3
	Placebo	18.1 (5.1)	19.1 (4.1)	1.0	5.5	4.29	0.337
Sleep efficiency, %	VLD CBP	73.6 (20.9)	85.1 (11.2)	11.5	15.6	19.56	0.023^†	0.099	–2.3
	Placebo	83.9 (13.4)	86.9 (8.7)	3.0	3.6	8.31	0.144

↵* Each t test is used to test that within-group change from baseline is significant, i.e., different from 0. p value is 2-sided.
↵** ANOVA p value comparing mean change from baseline between treatments.
↵† p ≤ 0.05.