Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia

Table 5 Change from baseline at open-label study endpoint in FIQ ‘tired upon awakening’ subscale and FOSQ

Parameter	Sodium oxybate final dose
	4.5 g	6 g	7.5 g	9 g	Total^a
FIQ subscale: ‘tired upon awakening’
Baseline, number	172	188	114	81	559
Mean (SD)	7.93 (1.77)	8.19 (1.74)	8.35 (1.69)	8.57 (1.48)	8.21 (1.71)
Endpoint, number	168	187	114	81	554
Mean change (SE)	−4.16 (0.25)	−4.56 (0.22)	−3.84 (0.31)	−4.88 (0.34)	−4.33 (0.13)
FOSQ total score
Baseline, number	162	182	114	79	541
Mean (SD)	14.00 (3.82)	13.73 (3.60)	13.20 (3.61)	12.76 (3.74)	13.56 (3.71)
Endpoint, number	157	181	114	79	535
Mean change (SE)	2.75 (0.30)	3.19 (0.27)	3.28 (0.37)	3.82 (0.42)	3.15 (0.16)

Study endpoint was defined as the last available data (study completion or early discontinuation). ^aIf the final dose was not among those indicated, the patient was summarized only for the ‘Total’ group. FIQ, Fibromyalgia Impact Questionnaire; FOSQ, Functional Outcomes of Sleep Questionnaire; SD, standard deviation; SE, standard error.

ISSN: 1478-6362