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SPECIAL SAFETY STUDIES

Special safety studies – Middle of the night

woman sleeping

In a randomized placebo trial in healthy female subjects ≥55 years and males ≥65 years:

Postural stability

Both DAYVIGO™ doses (5 mg and 10 mg) impaired balance (measured by body sway) at 4 hours post-dose compared with placebo.

Attention and memory

DAYVIGO™ was associated with dose-dependent worsening 4 hours post-dose on measures of attention and memory as compared with placebo.

Patients should be cautioned about the potential for middle of the night postural instability, as well as attention and memory impairment.

Awakening to sound

Neither DAYVIGO™ dose demonstrated any meaningful differences in patients’ ability to awaken to sound compared with placebo.

Special safety studies – Next Day

fireman smiling

In 2 randomized placebo trials in healthy subjects and insomnia patients ≥55 years of age:

Next-day cognitive performance

There was no difference between DAYVIGO™ (5 mg or 10 mg) and placebo in test of memory.

In a randomized, double-blind, placebo, 4-period crossover study of healthy volunteers (N=48):

Next-morning driving

DAYVIGO™ at doses of 5 mg and 10 mg did not cause statistically significant impairment in next-morning driving performance in adult or elderly subjects (compared with placebo). However, driving ability was impaired in some subjects taking 10 mg DAYVIGO™. Therefore, patients using the 10 mg dose should be cautioned about the potential for next-morning driving impairment.

Patients should also be cautioned as the risk of impaired driving is increased if DAYVIGO™ is taken with fewer than 7 hours sleep remaining or if a higher than recommended dose is taken.

WARNINGS AND PRECAUTIONS

RELEVANT WARNINGS AND PRECAUTIONS

  • Abnormal thinking and behavioural changes
  • CNS depressant effects (including alcohol) and daytime impairment
  • Complex sleep behaviours
  • Sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms
  • Worsening of depression/suicidal ideation
  • Co-morbid diagnoses
  • Drug interactions – inhibitors and inducers of CYP3A
  • Patients with galactose intolerance
  • Driving and operating machinery
  • Patients with dependence/tolerance and abuse liability
  • Patients with hepatic, biliary, or pancreatic impairment
  • Patients with compromised respiratory function
  • Pregnant or breastfeeding women

See Warnings and Precautions section of Product Monograph for complete list of warnings and precautions.

ADVERSE REACTIONS

DAYVIGO™ has a proven profile in safety

DAYVIGO™ was generally well tolerated

Percentage of Patients with Treatment-Emergent Adverse Events (Incidence ≥ 1% in any DAYVIGO™ treatment group where the incidence in the DAYVIGO™ group was more than placebo from SUNRISE 1 and SUNRISE 2.)

Other Adverse reactions

Sleep paralysis

Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, can occur with the use of DAYVIGO™. In clinical trials of DAYVIGO™, sleep paralysis was reported: DAYVIGO™ 5 mg 1.3% or DAYVIGO™ 10 mg 1.6% compared to no reports for placebo (see WARNINGS AND PRECAUTIONS).

Hypnagogic Hallucinations

Hypnagogic hallucinations were reported in 0.1% and 0.7% of patients receiving DAYVIGO™ 5 mg and 10 mg, respectively, compared to no reports for placebo (see WARNINGS AND PRECAUTIONS).

Complex Sleep Behaviours

Two events of complex sleep behaviour were reported, both in patients receiving DAYVIGO™ 10 mg (see WARNINGS AND PRECAUTIONS).

Seizure

One subject in clinical trials receiving DAYVIGO™ 25 mg experienced two events of seizure approximately 2 hours and 3.5 hours after taking study medication on the same evening. The subject had no prior history of seizure disorder, though it is not clear that the episodes experienced had a causal relationship to DAYVIGO™.


Studies show no clear evidence of physical dependence, withdrawal symptoms, or rebound insomnia

Physical dependence and withdrawal symptoms

In completed clinical trials with DAYVIGO™, there was no clear evidence for physical dependence or withdrawal symptoms with the prolonged use of DAYVIGO™ as assessed by the Tyrer Benzodiazepine Withdrawal Symptom Questionnaire.

Rebound insomnia

Rebound insomnia was assessed following discontinuation of DAYVIGO™ relative to placebo and baseline in both elderly and non-elderly adult patients receiving DAYVIGO™ 5 mg or 10 mg after 1 month and 1 year. No statistically significant effects were seen on measures of sleep onset latency or time awake after sleep onset in comparison to baseline values or relative to placebo.


Abuse Liability

In a human abuse liability study conducted in recreational sedative users (N=39), DAYVIGO™ (10, 20, and 30 mg) produced similar responses on positive subjective measures such as “Drug Liking”, “Overall Drug Liking”, “Take Drug Again”, and “Good Drug Effects” as zolpidem (30 mg) and suvorexant (40 mg), which were statistically significantly greater than placebo. Because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to DAYVIGO™, follow such patients carefully.


As with other hypnotics, care should be taken when prescribing DAYVIGO™ to individuals with a history of addiction to, or abuse of, drugs or alcohol due to risk of misuse or abuse.

Well tolerated over 6 months

In a 6-month, global, multicentre, randomized, double-blind, parallel-group phase III study, a similar incidence of adverse events was observed across the placebo, DAYVIGO™ 5 mg, and DAYVIGO™ 10 mg treatment groups.

DRUG INTERACTIONS

Concomitant use

Woman writing

DAYVIGO™ should not be prescribed concomitantly with:

  • Alcohol
  • Other sedative hypnotics
  • Opioids
  • Tricyclic antidepressants

Patients should be advised against combined use of DAYVIGO™ with other CNS depressants because of the potential for additive effects on psychomotor performance.

Use with CYP3A Inhibitors and Inducers

Avoid concomitant use of DAYVIGO with moderate or strong CYP3A inhibitors. The maximum recommended dose of DAYVIGO is 5 mg no more than once per night when co-administered with weak CYP3A inhibitors

See Drug Interaction section of Product Monograph for complete list of drug interactions.


Sleep disturbance may be the presenting manifestation of a physical and/or psychiatric disorder.
Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the
patient has been carefully evaluated.

DAYVIGO™ is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or
sleep maintenance.

Click here for additional safety information and for a link to the product monograph, discussing
contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical
use.