Assessing the Real-World, Long-Term Impact of Lemborexant on Sleep Quality in a Home-Based Clinical Study

Figures & data

Figure 1 Test schedule. *The dose is increased to 10 mg (LEM10) after consulting with a study physician based on the participant’s complaints.

Abbreviations: ESS, Epworth Sleepiness Scale; PSQI, Pittsburgh Sleep Quality Index; BDI, Beck Depression Inventory; TCI-HA, temperament and character inventory harm avoidance.

Table 1 Characteristics of Participants

	(N=31)
Sex (women)	16 (51.6%)
Age (yrs)	58.5±7.3 [50–72]
BMI (kg/m^2)	23.0±3.6
Comorbid diseases	23 (74.2%)
Concomitant medication	28 (90.3%)
Insomnia symptoms
Difficulty initiating sleep	19 (61.3%)
Difficulty maintaining sleep	26 (83.9%)
Waking up earlier than desired	19 (61.3%)
Duration of insomnia (yrs)	6.2±7.0 [0.5–30]
History of insomnia medication	8 (25.8%)
Objective sleep parameters (N=27)
Recording time (min)	378.5±87.6
LPS (min)	34.0±28.4
WASO (min)	52.4±31.3
TST (min)	293.0±81.5
SE (%)	76.5±11.3
Subjective sleep parameters
sSOL (min)	41.8±29.8
sWASO (min)	43.7±39.1
sTST (min)	286.0±96.0
sSE (%)	68.6±19.3
PSQI	8.9±2.3
ESS	11.9±4.2
TCI-HA	9.8±4.8
BDI	9.6±7.7

Abbreviations: BMI, body mass index; LPS, latency to persistent sleep; WASO, wake after sleep onset; TST, total sleep time; SE, sleep efficiency; sSOL, subjective sleep onset latency; sWASO, subjective wake after sleep onset; sTST, subjective total sleep time; sSE, subjective sleep efficiency; PSQI, Pittsburgh Sleep Quality Index; ESS, Epworth Sleepiness Scale; TCI-HA, temperament and character inventory harm avoidance; BDI, Beck Depression Inventory.

Figure 2 Participants through the trial.

Abbreviation: MRI, magnetic resonance imaging.

Table 2 Objective Sleep Parameters at Baseline, and 4^th and 12^th Weeks

	n	Mean±SD	Paired t-Test p value	MANOVA
				df	F	p value
LPS (min)
Baseline	27	34.0±28.4
At week 4	22	31.2±27.3
Change from baseline at week 4	18	7.5±26.0	0.237	16	1.59	0.224
At week 12	23	27.1±25.3
Change from baseline at week 12	22	−5.9±31.2	0.385	20	12.2	0.002
WASO (min)
Baseline	27	52.4±31.3
At week 4	22	44.1±30.9
Change from baseline at week 4	18	−9.4±41.7	0.352	16	11.7	0.003
At week 12	23	43.1±30.9
Change from baseline at week 12	22	−4.6±35.9	0.555	20	9.20	0.006
TRT (min)
Baseline	27	381.0±85.6
At week 4	22	401.9±79.5
Change from baseline at week 4	18	20.7±73.7	0.248	–	–	–
At week 12	23	380.7±76.1
Change from baseline at week 12	22	16.3±59.9	0.217	–	–	–
TST (min)
Baseline	27	293.0±81.5
At week 4	22	326.8±54.4
Change from baseline at week 4	18	23.5±64.3	0.140	16	22.1	<0.001
At week 12	23	309.3±64.3
Change from baseline at week 12	22	27.5±62.2	0.050	20	8.15	0.009
SE (%)
Baseline	27	76.5±11.3
At week 4	22	82.2±8.7
Change from baseline at week 4	18	3.0±5.5	0.032	16	1.40	0.252
At week 12	23	81.4±8.3
Change from baseline at week 12	22	4.6±9.5	0.033	20	16.4	<0.001

Abbreviations: SD, standard deviation; LPS, latency to persistent sleep; WASO, wake after sleep onset; TRT, total recording time; TST, total sleep time; SE, sleep efficiency; MANOVA, repeated-multivariate analysis of variance; df, degrees of freedom. MANOVA is performed with the baseline sleep parameters as covariates.

Table 3 Subjective Sleep Parameters at Baseline, and 4^th and 12^th Weeks

	n	Mean±SD	p value
sSOL (min)
Baseline	31	41.8±29.8
At week 4	31	16.9±10.1
Change from baseline at week 4	31	−24.8±27.9	<0.001
At week 12	29	14.6±8.6
Change from baseline at week 12	29	−27.9±28.9	<0.001
sWASO (min)
Baseline	31	43.7±39.1
At week 4	31	17.4±14.4
Change from baseline at week 4	31	−26.2±39.3	<0.001
At week 12	29	14.4±12.0
Change from baseline at week 12	29	−31.0±38.0	<0.001
sTST (min)
Baseline	31	286.0±96.0
At week 4	31	362.4±68.8
Change from baseline at week 4	31	76.4±66.2	<0.001
At week 12	29	369.2±88.3
Change from baseline at week 12	29	88.3±78.1	<0.001
sSE (%)
Baseline	31	68.6±19.3
At week 4	31	83.3±9.7
Change from baseline at week 4	31	14.6±16.0	<0.001
At week 12	29	86.8±8.4
Change from baseline at week 12	29	18.9±17.4	<0.001

Abbreviations: SD, standard deviation; sSOL, subjective sleep onset latency; sWASO, subjective wake after sleep onset; sTST, subjective total sleep time; sSE, subjective sleep efficiency.

Table 4 Sleep Disturbance, Daytime Sleepiness, and Depressive Symptoms at Baseline, and 4^th and 12^th Weeks

	n	Mean±SD	p value
PSQI
Baseline	31	8.9±2.3
At week 4	31	8.4±2.7
Change from baseline at week 4	31	−0.5±2.9	0.388
At week 12	29	7.8±2.0
Change from baseline at week 12	29	−1.2±2.4	0.012
ESS
Baseline	31	11.9±4.2
At week 4	31	8.7±3.8
Change from baseline at week 4	31	−3.2±4.4	<0.001
At week 12	29	8.0±4.0
Change from baseline at week 12	29	−4.3±4.7	<0.001
TCI-HA
Baseline	31	9.8±4.8
At week 4	31	9.6±4.9
Change from baseline at week 4	31	−0.2±3.2	0.699
At week 12	29	8.9±5.7
Change from baseline at week 12	29	−0.8±3.6	0.245
BDI
Baseline	31	9.6±7.7
At week 4	31	8.4±7.1
Change from baseline at week 4	31	−1.2±4.5	0.153
At week 12	29	6.4±6.5
Change from baseline at week 12	29	−3.1±5.2	0.003

Abbreviations: SD, standard deviation; PSQI, Pittsburgh Sleep Quality Index; ESS, Epworth Sleepiness Scale; TCI-HA, temperament and character inventory harm avoidance; BDI, Beck Depression Inventory.

Table 5 Safety Summary During Treatment and Follow-Up Periods

	No. (%)
Treatment-emergent adverse events	25 (80%)
Treatment related	13 (41%)
Severe	0
Serious	0
Leading to study discontinuation	1 (3%)
Leading to interruption of study drug	1 (3%)
Death	0
Treatment related adverse events
Somnolence	9 (29%)*
Headache	2 (6%)
Nightmare	1 (3%)
Constipation	1 (3%)

Notes: *lemborexant 5mg n=5, lemborexant 10mg n=4.